Clinical trial NCT04396795
Conditions: Erectile Dysfunction
Keywords: ED
Sponsor: University of Miami
Start date: 2020-05-21; Completion date: 2023-04-18
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate changes in vascular parameters and International Index of Erectile Function (IIEF) scores with the administration of Platelet Rich Plasma (PRP) to participants with Erectile Dysfunction (ED)

Detailed description:

Arms: arm 1: Participants in this group will receive 2 sessions of autologous PRP penile injection, each administered 1 month apart ± 7 days arm 2: Participants in this group will receive 2 sessions of placebo injection, each administered 1 month apart ± 7 days.
Interventions: intervention 1: Autologous Platelet Rich Plasma intervention 2: Saline solution
Intervention descriptions: intervention 1: Each injection session will consist of a total of 5 mL PRP infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum. intervention 2: Each injection session will consist of a total of 5 mL saline solution infused slowly over a 2-minute period; 2.5 mL each injected to the right and left corpus cavernosum

Protocol documents:
Prot_SAP_000.pdf: 
The University of Miami Miller School of Medicine
Department of Urology
Clinical Research Protocol 
Title:
A Randomized, Double-Blind, Placebo Controlled Trial on 
Safety and Efficacy of Autologous Platelet-Rich Plasma 
for Treatment of Erectile Dysfunction
Protocol No:
UM IRB#: 20200373
Protocol Version:
Version 1.3
Version Date:  1/23/2023
NCT#:
NCT04396795
Sponsor:
Telephone:
Fax:
Email:
Ranjith Ramasamy, MD
(305) 243 – 4562
(305) 243 – 3381
ramasamy@miami.edu
CONFIDENTIALITY STATEMENT
This document is confidential and proprietary to the University of Miami, Miller School of Medicine and its 
affiliates. Acceptance of this document constitutes agreement by the recipient that no unpublished 
information contained herein will be reproduced, published, or otherwise disseminated or disclosed 
without prior written approval of University of Miami Miller School of Medicine or its affiliates, except that 
this document may be disclosed in any medium to appropriate clinical investigators, Institutional Review 
Boards, and others directly involved in the clinical investigation that is the subject of this information under 
the condition that they keep the information strictly confidential
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University of Miami, Miller School of Medicine
**CONFIDENTIAL & PROPRIETARY**
Department of Urology
Protocol Version: 1.3
Version Date: 23 JAN 2023
Page 2 of 23
Investigator Signature Page
Title:
A Randomized, Double-Blind, Placebo Controlled Trial on Safety and 
Efficacy of Autologous Platelet-Rich Plasma for Treatment of Erectile 
Dysfunction.
I have read the enclosed protocol. I will ensure the safety of the study subjects enrolled under 
my supervision, and will provide the sponsor with complete, accurate, and timely information on 
this study, as outlined in this Protocol. The signature below constitutes approval of this protocol 
and the attachments and provides the required assurances that this trial will be conducted 
according to all stipulations of the protocol, including local legal and regulatory requirements, 
applicable US federal regulations and (ICF E6) guidelines. I shall hold strictly confidential all 
information pertaining to the study, and that this confidentiality requirement applies to all study 
staff at the site(s) and/or under my supervision. 
         Ranjith Ramasamy, MD          
        1/23/2023
      
Print Name for Principal Investigator 
Date
_____________________________
Principal Investigator Signature
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University of Miami, Miller School of Medicine
**CONFIDENTIAL & PROPRIETARY**
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Protocol Version: 1.3
Version Date: 23 JAN 2023
Page 3 of 23
Table of Contents
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS.................................4
PROTOCOL SYNOPSIS .......................................................................................5
1.
PROTOCOL TITLE.....................................................................................7
2.
BACKGROUND..........................................................................................7
3.
STUDY OBJECTIVES ................................................................................8
4.
STUDY ENDPOINTS ..................................................................................9
5.
STUDY LOCATION ....................................................................................9
5.1
ADDITIONAL STUDY SITES .....................................................................9
6.
STUDY POPULATION ...............................................................................9
7.
IDENTIFICATION AND ENROLLMENT OF SUBJECTS ........................10
7.1
RECRUITMENT AND PRE-SCREENING ................................................10
7.2
PAYMENT TO SUBJECTS ......................................................................11
7.3
INFORMED CONSENT ............................................................................11
7.4
WITHDRAWAL CRITERIA .......................................................................11
8.
PROCEDURES INVOLVED .....................................................................12
10.
DATA MANAGEMENT .............................................................................17
11.
DATA AND SPECIMEN BANKING..........................................................17
14.
RISKS TO SUBJECTS .............................................................................19
15.
POTENTIAL BENEFITS TO SUBJECTS.................................................19
17.
ETHICAL CONSIDERATIONS .................................................................20
18.
PUBLICATIONS .......................................................................................20
19.
REFERENCES..........................................................................................20
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List of Abbreviations and Definition of Terms
AE
Adverse Events
BPH
Benign Prostatic Hyperplasia
BRB
Biomedical Research Building
CNS
Central Nervous System
CRF
Case Report Form
CTCAE
Common Terminology Criteria for Adverse Events
eCRF
Electronic Case Report Form
ED
Erectile Dysfunction
EDITS
Erectile Dysfunction Inventory of Treatment Satisfaction
EDV
End Diastolic Velocity
GCP
Good Clinical Practice 
HIPAA 
Health Information Portability and Accountability Act
ICF
Informed Consent Form
ICH
International Conference of Harmonization
ICI
Intracavernosal Injection
IEC
Institutional Ethics Committee
IIEF
International Index of Erectile Function
IIEF-EF
Erectile Function Subdomain Score
IRB
Institutional Review Board
ISCI
Interdisciplinary Stem Cell Institute
MCID
Minimal Clinically Important Difference
mL
Milliliter
ng/dL
Nanograms Per Deciliter
PDE5i
Phosphodiesterase 5 inhibitor
PPP
Platelet Poor Plasma
PRFM
Platelet Rich Fibrin Matrix
PRP
Platelet Rich Plasma
PSV
Peak Systolic Velocity
RCT
Randomized Controlled Trial
SAE
Serious Adverse Events
SEP3
Sexual Encounter Profile
SOP
Standard Operating Procedure
SSRI
Selective Serotonin Reuptake Inhibitor
TE-SAE
Treatment Emergent Serious Adverse Events
UM
University of Miami
VAS
Visual Analogue Pain Scale
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Protocol Synopsis
TITLE
A Randomized, Double-Blind, Placebo Controlled Trial on Safety and 
Efficacy of Autologous Platelet-Rich Plasma for Treatment of Erectile 
Dysfunction
SPONSOR
University of Miami, Miller School of Medicine, Department of Urology
PHASE OF STUDY
Phase I 
STUDY THERAPY
Autologous Platelet-Rich Plasma (PRP)
STUDY DESIGN
Randomized, Double Blind, Placebo Controlled, Pilot Trial
ROUTE OF 
ADMINISTRATION 
Intracavernosal Injection
SUBJECT 
POPULATION
80 male subjects between the age of 30-75 with erectile dysfunction of 
organic origin
STUDY 
OBJECTIVES 
Primary: To investigate and compare the treatment efficacy of PRP vs 
placebo treatment in men with mild-moderate ED, as measured by IIEF.
Secondary: To study incidence of adverse events and safety of PRP injection 
treatment in men with mild-moderate ED, as measured by IIEF.
INVESTIGATION 
PLAN
80 men with Erectile Dysfunction (ED) of organic origin, that meet all of the 
inclusion and none of the exclusion criteria, will be randomized to receive, 
intracavernosal injection of either PRP or placebo in a 1:1 double-blinded 
fashion:
Group A (40 subjects): Autologous PRP 
All subjects in this group will receive 2 sessions of autologous PRP with 30 
± 7 day treatment interval. 5mL of PRP will be injected at each session.
Group B (40 subjects): Placebo (Normal Saline)
All subjects in this group will receive 2 sessions of normal saline with 30 ± 
7 day treatment interval. 5mL of normal saline will be injected at each 
session.
-
Patients will be followed for outcome assessments at 1, 3, and 6 
months post final injection.
DURATION OF 
STUDY
9 months (1 month screening, 2 therapy sessions 1 month apart, 6 months 
follow-up)
DEFINITION OF 
ENDPOINTS
Primary Endpoint (Efficacy)
-
The percentage of subjects in each group who attain MCID in IIEF-EF 
domain from baseline to 4 weeks after final treatment.
Secondary Endpoints (Efficacy)
-
The percentage of subjects in each group who attain MCID in IIEF-EF 
domain from baseline to 12 & 24 weeks after final treatment.
-
The difference between groups in change of IIEF-EF score from baseline 
to 4, 12, & 24 weeks after final treatment.
-
Differences in Doppler ultrasound parameters (PSV and EDV) from 
baseline to 24 weeks after final treatment.
Secondary Endpoints (Safety)
-
Incidence of adverse events in all patients during the study period.
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INCLUSION 
CRITERIA
1.
Be Male
2.
Be 30 to ≤75 years of age (inclusive).
3.
Be able to provide written informed consent.
4.
Have a diagnosis of ED due to organic origin for at least 6 months prior 
to consent.
5.
Sexually active in a stable, heterosexual relationship of more than three 
months duration.
6.
IIEF-EF score 11-25 at screening (even if taking a single PDE5i).
7.
Agree to attempt sexual intercourse at least 4 times per month for the 
duration of the study without being under the influence of alcohol or 
recreational drugs.
8.
Agree to comply with all study related tests/procedures.
EXCLUSION 
CRITERIA
1.
Previous penile surgery of any kind (except circumcision and 
condyloma removal), such as penile lengthening, penile cancer 
surgery, penile plication, grafting.
2.
Previous history of priapism or penile fracture
3.
Abnormal morning serum testosterone level defined as a value lower 
than 300 ng/dL (±5%) (indicative of untreated hypogonadism), or 
greater than 1197 ng/dL (±5%).
4.
Current or previous hormone usage, other than prescribed 
testosterone, clomiphene or thyroid medication. (Subjects with prior or 
current use of hormonal treatment for prostate cancer are also 
excluded.)
5.
Psychogenic ED as determined by study investigator.
6.
Anatomical (Peyronie’s Disease or penile curvature that negatively 
influences sexual activity) or neurological abnormalities in the treatment 
area.
7.
Patients using ICI for management of ED
8.
Patients with generalized polyneuropathy, or neurological conditions 
irrespective of cause, such as severe diabetes, multiple sclerosis or 
Parkinson’s disease.
9.
Have a serious comorbid illness/condition/behavior that, in the opinion 
of the investigator, may compromise the safety or compliance of the 
subject or preclude successful completion of the study.
10. History of consistent treatment failure with PDE5 inhibitors for therapy 
of ED.
11. Any history of significant psychiatric disease, such as bipolar disorder 
or psychosis, greater than one lifetime episode of major depression, 
current depression of moderate or greater severity. Patients who are 
currently using SSRI or psychotropic medications.
12. Hemoglobin a1c >9%.
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1. Protocol Title
A Randomized, Double-Blind, Placebo Controlled Trial on Safety and Efficacy of 
Autologous Platelet-Rich Plasma for Treatment of Erectile Function
2. Background
2.1 Platelet-based therapies
Platelet-derived therapies are a growing trend across multiple medical and surgical 
specialties including dermatology, ophthalmology, cardiology, colorectal surgery, plastic 
surgery and mainly orthopedics [1-2]. One of the most well described platelet-based 
therapies is autologous platelet-rich plasma (PRP) [3]. PRP is derived from the 
centrifugation of whole blood with a separator gel to remove the red and white blood cells. 
The resulting supernatant has a greater than four-fold increase in platelets and other 
plasma proteins [1]. This concentrate is then administered via injection. PRP has been 
frequently used for orthopedic conditions such as bone and soft tissue trauma, 
inflammatory conditions, and chronic pain syndromes [3-4]. Evidence suggests that 
platelets play an important role not only in coagulation but also in regulation of body 
metabolism, promotion of the wound healing, tissue regeneration, vascular remodeling 
and inflammatory/immune responses through secretion of growth factors, cytokines and 
chemokines [4-5]. These biologically active proteins include transforming growth factor-
β, platelet-derived growth factor, platelet-derived epithelial growth factor, insulin- like 
growth factor, vascular endothelial growth factor, basic fibroblast growth factor, as well as 
many others [6]. When platelets are activated, they release these growth differentiation 
factors, facilitating even nerve repair and regeneration [7-8]. Growth factors act locally 
and are implicated in many aspects of natural wound healing, including chemotaxis, cell 
proliferation, cell differentiation and angiogenesis. They also control and conduct 
synthesis, modification and degeneration of extracellular matrix proteins. Coordination of 
these cellular and molecular processes is integral to proper wound healing and tissue 
regeneration [9]. The key role of platelets in these processes makes them an attractive 
candidate for therapies aimed at accelerating natural healing, as well as tissue 
regeneration.
Autologous blood-based biomaterials are promising therapeutic options for varied 
pathology. Rapid generation of therapeutic material following collection allows for point-
of- care therapy [10]. Furthermore, an autologous therapy avoids the need for 
immunosuppression and eliminates concerns of rejection. Newer strategies to prolong 
the anti-inflammatory and wound healing properties of platelets have focused on creating 
a fibrin matrix (platelet rich fibrin matrix, PRFM) to bind the platelets and prevent 
extravasation from the site of injection, thereby addressing the concern of early washout 
with PRP [11]. In addition, PRFM offers a potential scaffold for tissue ingrowth and may 
allow continued release of platelet-related factors for a longer duration. Across multiple 
disciplines, PRP has been used both as a primary treatment modality and as a 
supplement to other therapies in hopes of supplementing wound healing, tissue 
regeneration, and angiogenesis. Although most of the studies focusing on PRP injections 
have been relatively small and heterogenous, they largely support the concept of 
administration in terms of safety, while efficacy remains uncertain. Finally, the concept of 
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autologous therapy has be shown in the real world that it is particularly attractive to 
patients [10].
2.2 Platelet-rich plasma treatment for erectile dysfunction
Erectile dysfunction (ED) affects as many as 1 in 4 men, and evidence indicates that 
incidence is rising [12-13]. The pathophysiology is multifactorial, but the most common 
pathophysiology, vasculogenic erectile dysfunction, has as first sign endothelial 
dysfunction secondary to inflammation [14]. The most common treatments for ED aim to 
improve endothelial function through augmentation of the nitric oxide pathway [15]. 
Return of potency after surgical injury of CNS partially depends on axon regeneration in 
the remaining neural tissue [16]. The process of regeneration and functional recovery of 
peripheral nerve is slow and is influenced by many factors [17] such as extracellular 
matrix, neurotrophic factors, and cellular components [18]. Recent advances in the 
understanding of molecular pathways and their physiological role demonstrate that 
growth factors are an important part of the development, maintenance, and regeneration 
of the nervous system [19]. Various growth factor neuromodulatory strategies, including 
insulin-like growth factor (IGF-I) and neurotrophic factors, are investigated to identify 
agents that may have neuroprotective and regenerative function after the occurrence of 
peripheral nerve injury. Accumulating evidence indicates that neuroimmunophilin ligand 
(such as FK506) plays a significant role in neural regeneration and upregulation of 
neuronal nitric oxide synthase (nNOS), as well as in the recovery of erectile function after 
CN injury occurrence [20-21]. FK506 neuroprotection after CN injury is mediated by 
antioxidative/nitrosative and anti- apoptotic pathway [22]. When platelets are activated, 
they release many kinds of growth differentiation factors and a few types have been found 
to facilitate nerve repair and regeneration. Moreover, corporeal dysfunction due to smooth 
muscle atrophy or other inracavernosal pathology can lead to corporo-venous occlusive 
erectile dysfunction despite a normal arterial inflow. Rejuvenating the Corporeal tissues 
with PRP, which is well known for its growth and healing factors, is a possible modality 
as a potential treatment for erectile dysfunction according to Alkhayal et al [23]. In their 
retrospective study examining the efficacy of one intra-cavernosal PRP injection to 40 ED 
patients, they reported that mean IIEF-5 score before treatment was 13 (5-20) and post 
treatment IIEF-5 = 17 (7-24), (p < 0.001). Other studies have shown similar results with 
minimal side effects, no serious adverse reactions and potential efficacy (Table 1) [23-
26].
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Table 1: Summary of published studies and abstracts
To date, there are no treatments that address the underlying cause of endothelial 
dysfunction, although LIST treatment for ED has shown promising results. Platelet-
derived therapies targeting inflammation and promoting tissue/nerve regeneration and 
may represent a potential treatment option towards this direction. Despite growing 
evidence to the efficacy of PRP, no randomized placebo-controlled studies exist. 
3. Study Objectives
3.1 Primary Objective:
To investigate and compare the treatment efficacy of PRP vs placebo treatment in men 
with mild-moderate ED, as measured by IIEF.
3.2 Secondary Objective:
To study the adverse events and safety of the PRP treatment in in men with mild-
moderate ED, as measured by IIEF.
4. Study Endpoints
4.1 Primary Endpoint:
-
The percentage of subjects in each group who attain MCID in IIEF-EF domain from 
baseline to 4 weeks after final treatment.
4.2 Secondary Endpoints (efficacy):
-
The percentage of subjects in each group who attain MCID in IIEF-EF domain from 
baseline to 12 & 24 weeks after final treatment.
-
The difference between groups in change of IIEF-EF score from baseline to 4, 12, & 
24 weeks after final treatment.
Author
Year
Number 
of 
Patients
Patient 
Population
Administration
Followup
Adverse Events
Conclusion
Banno 
[26]
2017
N=9
Penile 
Rehab 
PRP ICI into Pnies 
with Vacuum 
Device
4 weeks
No  AEs reported
PRP may represent a safe and viable option as 
a supplementary therapy for penile 
rehabilitation. Particularly notable is the 
prospect of zero side effects.
Matz [24]
2018
N=16
Erectile 
dysfunction, 
Peyronies 
Disease
PRP with CaCl ICI 15.5m
Minor: Bruising 1, 
Mild Pain 4.              
Major: none
PRFM injections for ED, PD, and female SUI are 
feasible and safe. Although the limited data is 
suggestive of efficacy, a placebo control will 
be required in subsequent efforts for 
confirmation
Epifanova 
[25]
2019
N=10
Erectile 
Dysfunction
6 injections PRP 
with CaCl2 ans 
Shockwave
60 Days
No AEs reported
There were no serious adverse events as well 
as severe adverse events. Erectile dysfunction 
symptoms in all men participated in the study 
significantly decreased after treatment with 
PRP-therapy and extracorporeal shockwave 
therapy 
Alkhayal 
[23]
2018
N=40
Erectile 
Dysfunction
1 injection PRP
> 1 month
No AEs reported
Platelet rich plasma is a safe and efficacious 
option for penile rejuvination and 
improvement of erectle dysfunction
Human Studies of PRP for ED
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-
Differences in Doppler ultrasound parameters (PSV and EDV) from baseline to 24 
weeks after final treatment.
4.3 Secondary Endpoints (safety):
-
Incidence of adverse events in all patients during the study period. Anticipated 
adverse events that will be recorded at every visit are the following 
o
Pain 
o
Bruising
o
Swelling
o
Edema
o
Allergy 
o
Penile Fracture 
o
New Penile Curvature
4.4 Exploratory Endpoints:
-
Change in stretched penile length from baseline to 24 weeks after final treatment.
-
The percentage of subjects in each group who attain MCID in IIEF-EF domain from 
baseline to 4 weeks after final treatment.
5. Study Location
The study will be funded by the Department of Urology and coordinated by the University 
of Miami (UM), Miller School of Medicine, Department of Urology. The UM 
Interdisciplinary Stem Cell Institute (ISCI) will also support the project (logistics, quality 
control, management, storage of specimens and data). All study visits will be carried out 
in the Department of Urology clinics, (ADDRESS: 1150 NW 14th Street, Suite 309, 
University of Miami Miller School of medicine, Miami, FL. & Lennar address) PRP 
preparation will take place in the clinic’s andrology lab.
5.1 Additional Study Sites
No additional study sites.
6. Study Population
80 males with ED of organic origin. All patients will be regular PDE5i users/responders. 
After a 1-month wash-out period for PDE5i, men with ED will be evaluated by IIEF-EF 
domain and eligible patients will be randomized to one of 2 treatment groups with an 
equal allocation ratio (1:1). Participants who do not adhere to the 1-month wash-out 
period, or do not meet the IIEF-EF domain score will be considered a screen failure and 
will not receive the study therapy.
6.1 Inclusion criteria: In order to participate in this study, a patient must:
1) Be Male
2) Be 30 to 75 years of age (inclusive).
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3) Be able to provide written informed consent.
4) Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.
5) Sexually active in a stable, heterosexual relationship of more than three months 
duration.
6) IIEF-EF score 11-25 at screening (even if taking a single PDE5).
7) Agree to attempt sexual intercourse at least 4 times per month for the duration of 
the study without being under the influence of alcohol or recreational drugs.
8) Agree to comply with all study related tests/procedures.
6.2 Exclusion criteria: In order to participate in this study, a patient must not:
1) Previous penile surgery of any kind (except circumcision and condyloma 
removal), such as penile lengthening, penile cancer surgery, penile plication, 
grafting.
2) Previous history of priapism or penile fracture
3) Abnormal morning serum testosterone level defined as a value lower than 300 
ng/dL (±5%) (indicative of untreated hypogonadism), or greater than 1197 ng/dL 
(±5%).
4) Current or previous hormone usage, other than prescribed testosterone, 
clomiphene or thyroid medication. (Subjects with prior or current use of hormonal 
treatment for prostate cancer are also excluded.
5) Psychogenic ED as determined by study investigator.
6) Anatomical (Peyronie’s Disease or penile curvature that negatively influences 
sexual activity) or neurological abnormalities in the treatment area.
7) Patients using ICI for management of ED
8) Patients with generalized polyneuropathy, or neurological conditions irrespective 
of cause, such as severe diabetes, multiple sclerosis or Parkinson’s disease.
9) Have a serious comorbid illness/condition/behavior that, in the opinion of the 
investigator, may compromise the safety or compliance of the subject or preclude 
successful completion of the study.
10)History of consistent treatment failure with PDE5 inhibitors for therapy of ED.
11)Any history of significant psychiatric disease, such as bipolar disorder or 
psychosis, greater than one lifetime episode of major depression, current 
depression of moderate or greater severity. Patients who are currently using SSRI 
or psychotropic medications.
12)Hemoglobin a1c >9%.
7. Identification and Enrollment of Subjects
7.1   Recruitment and Pre-screening
The research coordination team may develop materials to aide in recruitment. This may 
include, but is not limited to, informational videos and brochures which provide education 
about erectile dysfunction and include information about the study; physician referral letter 
templates which can be used to promote awareness of the study in the urology 
community; flyers/posters which can be utilized at approved clinic locations and as part 
of health fair materials; templates for print advertisements which can be utilized in 
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newsprint and media campaigns. Not all materials have been developed prior to trial 
initiation, however each of these recruitment methods will be reviewed and approved by 
the IRB prior to use.
Pre-screening of subjects includes reviewing medical records and imaging studies for 
inclusion/exclusions prior to consent. From the review of subjects’ medical records and 
imaging studies on file, subjects who are determined to have a diagnosis of erectile 
dysfunction of organic origin, and have mild-moderate erectile function as assessed by 
IIEF-EF, as stated in Section 6.1, and also do not have evidence in their medical record 
of study exclusions stated in Section 6.2, are eligible to be consented to the study.
Investigators will inform research staff of potential participants who have been identified 
through pre-screening so the subjects can be approached to discuss the study and 
conduct the informed consent session. No study procedures will take place prior to the 
subjects signing of the informed consent form. 
7.2   Payment to Subjects
No payments will be made to subjects as compensation for their participation in this study. 
The subjects will not be asked to pay for the treatments or participation in study either. 
7.3   Informed Consent
7.3.1 Consenting Process
All subjects must provide written consent to participate in this study. An informed consent 
form (ICF) will be given to each subject. The ICF will contain all United States federally 
required elements, all International Conference of Harmonization of Technical 
Requirements for Registration of Pharmaceuticals for Human Use (ICH) required 
elements, and Health Insurance Portability and Accountability Act Authorization (HIPAA) 
information in language that is understandable to the subject. The informed consent 
includes descriptions of all study related procedures, all possible risks to participant, and 
the time commitment involved with participating. All consent forms will have IRB approval. 
The ICF and review must be in a form understandable to the subject. Translation of ICFs 
will be done in accordance with local IRB procedures.
Potential participants will be approached by one of the study investigators or research 
coordinators. Information regarding study participation will be provided to the potential 
participant prior to consent. Subjects will be given ample time to review the ICF and ask 
questions before signing. The Investigator or designee and the subject must both sign 
and date the ICF after review, and before the any study procedures are performed. The 
subject will receive a copy of the signed and dated form, and the original will be retained 
in the site study files. The research staff member obtaining consent will document the 
informed process in the subject’s chart for monitoring purposes. The Investigator or 
his/her designee must emphasize to the subject that study participation is entirely 
voluntary and that consent regarding study participation may be withdrawn at any time 
without penalty or loss of benefits to which the subject is otherwise entitled.  
7.3.2 Non-English Speaking Subjects
In addition to English-speaking subjects, Spanish-speakers will also be included in the 
trial. A certified translated version of the IRB approved English consent form will be made 
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available to non-English speakers. Spanish version questionnaires and other patient-
facing materials will also be made available.
7.4 Withdrawal Criteria
All subjects who either screen fails, is withdrawn from the study, or has completed all 
visits should be de-enrolled from the research database within 2 business days, in 
accordance with university policies (or respective institutional policy).
Subjects may be withdrawn from the study for any of the following reasons:
a) A subject does not meet the eligibility criteria (the subject will be considered a 
screen failure).
b) A subject withdraws consent
c) A subject expires during protocol participation from causes other than the study 
treatment (not due to adverse events)
d) At the discretion of the principal investigator for issues of non-compliance, or other 
behavioral factors.
8. Procedures Involved 
72 men with Erectile Dysfunction (ED) of organic origin, that meet all of the inclusion and 
none of the exclusion criteria, will be randomized to receive either PRP, or placebo in a 
1:1 double-blinded fashion.
a) Group A (40 subjects): Autologous PRP injection. All subjects in this group will 
receive 2 sessions of autologous PRP penile injection with 30 ± 7 day treatment 
interval. 10mL of PRP will be injected at each session.
b) Group B (40 subjects): Placebo (Normal Saline). All subjects in this group will 
receive 2 sessions of normal saline penile injection with 30 ± 7 day treatment 
interval. 10mL of normal saline will be injected at each session.
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8.1 Schedule of Events
The time and events table for the conduct of this study is shown below:
Table1:
Study Phase
Screening
Injection
Follow Up
Time Point
V1
V2
V3
V4
V5
V6
Visit Window
0 - 28days prior 
to therapy
Day 0
Day 28 
± 7
Week 4
Day 30 ± 7
Week 12
Day 90 ± 7
Week 24
Day 180 ± 7
Informed Consent
X
Demographics
X
Medical History
X
Physical Exam
X
Doppler Ultrasound
X
X
Concomitant 
Medications/Therapy
X
X
X
X
X
X
Review Adverse Events
X
X
X
X
X
Randomization
X
Study Therapy Injection
X
X
IIEF 
X
X
X
X
SEP3
X
X
X
X
EDITS
X
X
X
Questionnaires
VAS
X
X
Hematology
X
Chemistry
X
HbA1c
X
Laboratory 
Testing
Testosterone 
X
8.2 Description of Study Procedures 
8.2.1 Informed Consent: Refer to Section 7.3 for details regarding the informed consent 
process. Study procedures will be completed only after participants have signed 
the informed consent documentation.
8.2.2 Demographics: Demographic characteristics will be recorded including: date of 
birth, gender, marital status, race and ethnicity. If Medical history has been 
recorded as part of their participation in another study those source documents 
may be requested and used for the purpose of this research study.
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8.2.3 Medical History: Assessment of current and past medical, surgical, and social 
history will be conducted.
8.2.4 Physical Examination: Genitourinary/Reproductive system physical exam will be 
performed.
8.2.5 Doppler Ultrasound:  Penile Doppler ultrasound will be performed as standard of 
care for the management of erectile dysfunction. Results from within the past 12 
months can be extracted from the medical record for use in this study.
8.2.6 Concomitant Medications: Review of current use of prescription and over the 
counter (OTC) medications. Participants must discontinue use of PDE5i 
medications throughout the duration of the study.
8.2.7 Review Adverse Events: Refer to Section 12 for description and reporting of 
adverse and serious adverse events
8.2.8 Randomization: Refer to Section 9.3 for details about randomization plan 
8.2.9 Study Therapy Injection: Approximately 120mL of blood will be collected from 
participants for preparation of investigational product. Refer to Section 9.2 for 
description of IP preparation and administration.
8.2.10 International Index of Erectile Function (IIEF) Questionnaire: This validated 
15-item self-evaluation scale provides pre and post treatment clinic evaluations of 
erectile function, orgasmic function, sexual desire, satisfaction in sexual 
intercourse and general satisfaction. If the subject has completed the IIEF 
questionnaire within the past 6 months, those results may be requested and used 
for the purpose of this research study. Questionnaires will be completed prior to 
therapy at injection visits.
8.2.11 Sexual Encounter Profile (SEP3) Questionnaire: This 5-item questionnaire is 
completed after each sexual intercourse attempt. Participants will be asked to 
complete the short version consisting of question #2 and #3 only.
8.2.12 Erectile 
Dysfunction 
Inventory 
of 
Treatment 
Satisfaction 
(EDITS) 
Questionnaire: This is a psychometrically sound questionnaire used to assess 
satisfaction with medical treatment modalities for erectile dysfunction.
8.2.13 Visual Analogue Pain Scale (VAS): The visual analog scale (VAS) is a validated, 
subjective measure for acute and chronic pain. Scores are recorded by making a 
handwritten mark on a line that represents a continuum between “no pain” and 
“worst pain”.
8.2.14 Laboratory Testing: Hematology, chemistry, hemoglobin A1C, and serum 
testosterone, lab test results will be recorded at screening. If any standard of care 
labs tests have been performed within 12 months of visit date, those results may 
be used for the purpose of this study.
8.3 Description of Study Visits
8.3.1 Visit 1: Screening Visit
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Visit 1 (0 – 28 days before therapy): The basic work-up will take place, including medical 
and sexual history, as well as necessary lab tests (testosterone, prolactin, hematology, 
chemistry), if not available during the last 12 months prior to screening. Subjects will 
complete the IIEF-ED questionnaire. We will ensure that patients have 4 attempts for 
intercourse, which they will record on the SEP diaries. PDE5i use is prohibited throughout 
the study. Screening visit can occur on same day as first injection. Refer to table 1 for 
procedures to be performed at the Screening visit.
8.3.2 Visit 2-3: Injection Visits (Day 0 & Day 28)
All participants will complete the IIEF questionnaire, and SEP diaries will be evaluated. 
Upon evaluation of eligibility, subjects will be randomized to one of the 2 parallel study 
groups, using an online program, and initiate treatment on the same day. 
There will be 2 treatment visits for all Groups with 28 ± 7 days treatment interval for all 
subjects. Subjects will complete a Visual Analogue Scale (VAS) pain score after the end 
of each treatment. Refer to table 1 for all procedures to be performed at the Intervention 
Visits.
8.3.3 Visit 4-6: Follow Up Visits (Week 4, 12, 24) Post-Injection
Follow up visits will occur within 30 ± 7 days of final injection (V3). Refer to table 1 for 
procedures to be performed at the follow up visits visit.
9. Investigational Product
9.1 Preparation of IP
Autologous Platelet-Rich Plasma (PRP) is prepared by taking 120 mL aliquots of 
anticoagulated blood (120 mL whole blood and 16 ml anticoagulant citrate dextrose 
formula A) obtained from each treatment subject by venipuncture. Each aliquot is 
processed by an autologous platelet separator (Arthrex Angel, Arthrex Inc., Naples, 
Florida) to yield 3-10 mL of PRP from each subject. Platelet poor plasma (PPP) can be 
added to PRP to achieve the desired injection volume. This system is FDA approved by 
501k for “clinical laboratory or intraoperatively at the point of care for the safe and rapid 
preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a 
small sample of whole blood or a small mixture of blood and bone marrow”. For patients 
randomized to the control arm, they will still have their blood drawn, however it will not be 
processed to make PRP.
9.2 Administration of IP
The patient will be positioned supine. A sterile field will be developed with Betadine prep 
of the genitalia, sterile gloves and a sterile extremity drape. A total of 20 ml of 1% lidocaine 
will be drawn up using an 18-gauge needle and will be subcutaneously administered 
using a 27-gauge needle into the subcutaneous tissue at the base of the penis to obtain 
a dorsal nerve block. A 1/4-inch Penrose drain will be used as a tourniquet by placing it 
at the base of the penis and maintaining it in place under tension by a sterile clamp. A 
maximum of 5mL  of PRP will be infused steadily over a two-minute period – 
approximately 2.5 ml each into the right and left corpus cavernosum. The infusion will be 
performed at this slow speed (each side over 2 minutes of infusion) to minimize injury to 
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the platelet cells. In the control arm, men will be administered injectable normal saline 
that will be injected in a similar manner as the PRP. 
Following administration of PRP or normal saline, compression of the penis will be 
achieved with a clenched fist for 20 minutes. At 20 minutes, the tourniquet will be 
removed, and a compressive dressing will be placed around the penile shaft. The patient 
will be instructed to remove the compression bandage in 4 hours and to contact the study 
coordinators if he experiences any problems. 
Figure 1: Diagram of PRP Injection
9.3 Randomization
On Day 0 (V2), participants who remain eligible for the trial will be randomized to one of 
two groups in a 1:1 ratio. The randomization sequence will be computer generated by the 
study coordinating team.
9.4 Blinding 
The study will remain double-blind by having both blinded and unblinded study teams. All 
subjects, active-therapy and placebo groups will undergo blood collection procedure on 
day of intervention visits. Preparation of PRP and normal saline injections will be 
conducted only by unblinded research team members. In the interest of safety, the study 
product must be inspected to ensure it is free of air bubbles, clumping, etc.
The 10cc syringes used will be colored and covered in both groups in order to ensure the 
double-blindness of the study.
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If for important medical reasons unblinding of additional team members is thought to be 
necessary, the Investigator may identify the treatment assignment by obtaining 
randomization records from unblinded study team.
10.Data Management
Data will be entered from source documents into eCRFs which are maintained in an online 
research database. The investigator will ensure data integrity by confirming the CRF’s 
are attributable, legible, contemporaneous, original, accurate, and complete.
10.1
Case Report Forms (CRFs)
The Investigator or designee must record all required subject data, and an explanation 
must be documented for any missing data. This study will use electronic case report forms 
(eCRF) for data entry and database storage.
10.2
Source Documents
Source data is all information, original records of clinical findings, observations, or other 
activities in a clinical trial necessary for the reconstruction and evaluation of the trial. 
Source data are contained in source documents.  Examples of these original documents, 
and data records include: hospital records, clinical and office charts, laboratory notes, 
memoranda, subjects’ diaries or evaluation checklists, recorded data from automated 
instruments, copies or transcriptions certified after verification as being accurate and 
complete, and records kept at medical technical departments involved in the clinical trial. 
All corrections to study data will be made by drawing a single line through the information 
to be corrected without obscuring it.  All corrections will be initialed, dated and explained, 
if necessary, in accordance with good clinical practice (GCP) guidelines.
10.3
Study Monitoring, Auditing, and Inspecting
The investigator will permit study-related monitoring, audits, and inspections by the IRB, 
government regulatory bodies, and University compliance and quality assurance groups 
of all study related documents. The investigator will ensure the capability for inspections 
of applicable study-related facilities.
11.Data and Specimen Banking
11.1
Storage of Data
Data will be maintained on research team hardware, and subject charts will be stored in 
a filing room maintained by Department of Urology. Clinical follow up and laboratory data 
will be stored in a locked room, with access only to authorized personnel. It is up to the 
principal investigator’s discretion as to how long non-FDA study essential documents are 
retained.
11.2
Specimen Banking
Bio-specimens will be reserved for future testing and stored at -80 degrees Celsius in 
equipment maintained by ISCI in the Biomedical Research Building (BRB) (address: 1501 
NW 10th avenue Miami FL 33136). Each specimen must have a corresponding requisition 
form to track the chain of custody from time of collection to time of processing and/or 
storage.
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12.  Safety Monitoring and Reporting
12.1
Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical 
occurrence associated with the use of a drug in humans, whether 
or not considered drug related. An AE can be any unfavorable and 
unintended sign (including an abnormal laboratory finding), 
symptom, or disease temporally associated with the study. The 
event does not need to have a causal relationship with treatment. 
Common Terminology Criteria for Adverse Events Version 5 
(CTCAE) will be used for describing AEs. All urological and/or 
reproductive system AEs will be recorded. For all other AEs, only 
events greater than grade 2 will be recorded.
We anticipate there to be few adverse events related to the study. 
Based on the four published studies and abstracts, including 75 
men, only minor adverse events were reported (Bruising 1, Mild 
Pain 4). No serious adverse events were observed [23-26] (Table 2)
12.2
Serious Adverse Events (SAEs)
A serious adverse event (SAE) is defined as an AE which, in the view of the Investigator 
results in: 1) Death; 2) a life-threatening event (i.e. an event in which the subject was at 
risk of death at the time of the event; it does not refer to an event which hypothetically 
might have caused death if it were more severe); 3) inpatient hospitalization of > 24 hours 
or prolongation of existing hospitalization; 4) a significant disability/incapacity; or 5) a 
congenital anomaly/birth defect. Other important medical events may be considered 
SAEs if, in the opinion of the Investigator, they jeopardize the subject or require 
intervention to prevent one of the other outcomes listed above. Based on prior 
investigations, we do not anticipate any SAEs related to the study procedures [23-26]
Treatment Emergent Serious Adverse Events (TE-SAEs) 
A treatment emergent serious adverse event (TE-SAE) is defined as any serious adverse 
event for which there is a reasonable possibility that the investigational product caused 
the adverse event. For the purposes of safety reporting, “a reasonable possibility” means 
there is evidence to suggest a causal relationship between the study product/procedures 
and the adverse event.
12.3
Reporting Responsibilities of the Investigator
Safety monitoring and reporting will be conducted in accordance with all university and 
departmental standard operating procedures (SOP). The study investigators will report to 
a surgeon monitor (Dr. Nicholas Hauser) who is not directly involved in the study, and 
has been delegated by the sponsor to ensure data quality and subject safety. The 
investigators will conduct continuous reviews of the safety data, keep track of SAEs and 
TE-SAEs, which will be discussed at research committee meetings once every 3 months.
Common Terminology Criteria for Adverse Events, Version 5 (CTCAE v5.0) will be used 
to assess severity of adverse events. All grade 3-5 adverse events, regardless of 
Pain 
4
Bruising
1
Swelling
0
Edema
0
Allergy 
0
Penile 
Fracture 
0
New 
Penile 
Curvature
0
Adverse Events 
Reported N=75
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association with the IP, will be entered into study database and reviewed at research 
committee meetings. In addition, all SAEs will be entered into research database and 
reviewed by the surgeon monitor on an ongoing basis. If a death occurs within 30 days 
of investigational therapy, and is determined to be related to the study, the investigators 
will notify the Urology Department Chair (Dr. Dipen Parekh) within 1 business day. If an 
increase in the frequency of grade 3 or 4 adverse events is noted in the study, a report 
will be submitted to the Department Chair at the time the increased rate is identified. If at 
any time the principal investigator stops enrollment or stops the study due to safety 
issues, the Department Chair will be notified within 1 business day and a formal letter will 
be sent to the Department Chair to be received within 10 business days.
13.  Statistical Considerations
13.1
Data Analysis Plan
Analysis plan: Continuous data will be analyzed using ANOVA with repeated measures, 
or student’s T-Test (where applicable) in order to compare differences between the 
treatment and control groups. For categorical data, Fisher’s Exact test to determine 
differences between groups. Statistical significance will be evaluated using α=0.05. 
13.2
Sample Size
Inclusion Criteria are men with IIEF scores >11 which includes men with mild (IIEF 16-
21) and mild/moderate (12-16) Erectile dysfunction. Minimal clinically important 
differenced (MCID) for these groups are an increase of 2 for mild and 5 for moderate ED.  
Previous studies on the effect of placebo show about a 15% improvement in men with 
mild to moderate ED. Therefore, 15% of the placebo group is expected to meet MCID. 
Results from the PRP safety study by Matz et al. 2018, which showed a mean 
improvement in IIEF of 4.14 points in seven patients with ED after PRP. In the 
interventional group, we expect 50% to meet MCID. At 80% power, we will therefore need 
30 patients in each group to detect a difference of 35% between treatment and placebo 
arms.
28.08 = (2*(1.96+0.84)2 * (0.25*(1-0.25)) / (0.352)
Assuming attrition of approximately 20%, an additional 6 participant slots will be added 
to each group for a total sample size of 80 subjects.
14.  Risks to Subjects
We anticipate there to be few adverse events related to the study. Based on the four 
published studies and abstracts, including 75 men, only minor adverse events were 
reported (Bruising 1, Mild Pain 4). No serious adverse events were observed [23-26] 
(Table 2). After literature review, we believe this product to be of non-significant risk to 
patients (NSR) and for investigational use in a clinical study protocol. 
Based on published studies, we will record anticipated adverse events to patients include: 
local injection cite reaction, penile plain and penile bruising. Additionally, we anticipate 
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patients may experience, penile swelling, allergic reaction, local infection (though none 
reported in previous studies) and will record them at every visit systematically.
15.  Potential Benefits to Subjects
The potential benefits for men randomized to the treatment arm will include improvement 
in erectile function and sexual performance.
16.  Privacy & Confidentiality
Each subject’s protected health information will remain strictly confidential and shall be 
excluded from the database. Patients deemed eligible to participate in the study following 
evaluation of inclusion/exclusion criteria will be assigned a unique study participant 
identifier number (ex.: 01-PRP01-001). The first two characters indicate the enrolling site, 
next 5 characters describe the study and phase, and final 3 characters are the unique 
identification number assigned to subjects in sequential order. Only each participant’s 
initials, assigned study participant identifier number, and date of birth may be documented 
in the database. The Investigator will retain a cross-referencing record of each subject’s 
name and assigned identifier number. All study data and results will be stored in the 
electronic database. Each study subject will give explicit consent for representatives of 
the IRB/IEC and regulatory authorities to inspect and verify each subject’s medical 
records and collected information. In turn, each study subject will be assured that all their 
personal information will be maintained in the strictest of confidence, and in compliance 
with HIPAA, and all other federal and local laws regulating privacy and data protection.
17.  Ethical Considerations
17.1
   Regulatory Authority Approval
This study will be conducted in accordance with Good Clinical Practice (GCP) 
requirements described in the current revision of International Conference on 
Harmonization of Technical Requirements of Pharmaceuticals for Human Use (ICH) 
Guidelines and all applicable regulations, including current United States Code of Federal 
Regulations (CFR), Title 21, Parts 50, 54, 56, and Title 45, Part 164. Compliance with 
these regulations and guidelines also constitutes compliance with the ethical principles 
described in the current revision of the Declaration of Helsinki.  This study will also be 
carried out in accordance with local legal requirements. 
According to FDA guidance issued to institutional review boards and investigators, we will 
use PRP for ED (an indication not approved on the labeling) while simultaneously 
“bearing the responsibility to be well informed about the product,  base its use on firm 
scientific rationale and on sound medical evidence, and to maintain records of the 
product’s use and effects.”
We believe that according FDA regulation, the clinical investigation of PRP for ED does 
not require submission of an IND / IDE since all six of the following conditions are met:
i.
it is not intended to be reported to FDA in support of a new indication for use or to 
support any other significant change in the labeling for the drug;
ii.
it is not intended to support a significant change in the advertising for the product;
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iii.
it does not involve a route of administration or dosage level, use in a subject 
population, or other factor that significantly increases the risks (or decreases the 
acceptability of the risks) associated with the use of the drug product;
iv.
it is conducted in compliance with the requirements for IRB review and informed 
consent [21 CFR parts 56 and 50, respectively];
v.
it is conducted in compliance with the requirements concerning the promotion and 
sale of drugs [21 CFR 312.7]; and
vi.
it does not intend to invoke 21 CFR 50.24.
17.2
   Ethics Approval
The investigators agree to conduct the study in compliance with the protocol, current good 
clinical practices, and all applicable (local, FDA) regulatory guidelines and standard of 
ethics.
It is the Investigator’s responsibility to ensure that, prior to initiating this study, this protocol 
is reviewed and approved by the appropriate local and/or external IRB.  The composition 
and conduct of this committee must conform to the United States CFR. The IRB/IEC must 
also review and approve the site’s informed consent form (ICF), other written information 
provided to the subject.
If it is necessary to amend the protocol or the ICF during the study, the Sponsor-
Investigator will be responsible for ensuring that the IRB/IEC reviews and approves these 
amended documents. An IRB/IEC approval of the amended protocol and/or ICF must be 
obtained in writing before implementation of the amended procedures and before new 
subjects are consented to participate in the study using the amended version of the ICF.
17.3
  Conflict of Interest
Any investigator who has a conflict of interest with the study must have the conflict 
reviewed by a properly constituted Conflict of Interest Committee with the Committee-
sanctioned conflict management plan that has been reviewed and approved by the study 
sponsor prior to participation in this study. All investigators will follow the University of 
Miami’s (or applicable institution’s) conflict of interest policy.
18.  Publications
The preparation and submission of manuscripts for publication that contain results from 
this study shall comply with all applicable privacy laws and in accordance with processes 
determined by the University of Miami, Miller School of Medicine.
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