Clinical trial NCT02344849: Safety of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Erectile Dysfunction
Official title: An Open, Single-center, Phase 1 Study to Evaluate Safety of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Erectile Dysfunction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Erectile Dysfunction
Lead sponsor: Pharmicell Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-01-26
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase I clinical trial is designed to evaluate the safety of autologous Mesenchymal Stem Cells (MSC) injected intracavernously.

Detailed description: Cellgram-ED is autologous bone marrow-derived mesenchymal stem cells ex vivo expanded for approximately 30 days. Ten patients (Diabetes -associated ED; 5 patients, Postprostatectomy; 5patients) will be injected Cellgram-ED directly into the intracavernous. Patient will be evaluated the safety and potential efficacy of MSC.

Eligibility criteria: Inclusion Criteria:

Postprostatectomy Erectile Dysfunction

* A man aged 20 or older
* Who is willing to consent to participate in the study concerned with improving sexual activity after prostatectomy, the man has maintained normal sexual activity prior to prostatectomy
* Prior to prostatectomy PSA (prostate specific antigen) level\<10 ng/mL
* At the time of Prostatectomy, Pathological Gleason sum ≤7
* At the time of Prostatectomy, Pathological stage ≤ T2c
* 2 years or more postprostatectomy patients with PSA level ≤ 0.04 ng/mL without additional therapy after prostatectomy
* Who cannot satisfy sexual activity(more than 4 times) with proper sexual stimulation in spite of taking maximum dose of oral PDE5I(phos-phodiesterasetype-5 inhibitors) within last 8weeks.
* IIEF, EF(erectile function) domain score is under 17
* Have a consistent partner who is willing to engage in sexual activity more than twice per month during the study.

Diabetes-associated Erectile Dysfunction

* HbA1c is between 6.5% and 10% of man over 20 years of age with diabetes
* Who cannot satisfy sexual activity(more than 4 times) with proper sexual stimulation in spite of taking maximum dose of oral PDE5I within last 8weeks.
* IIEF, EF domain score is under 17
* Who is willing to consent to participate in the study concerned with improving sexual activity
* Have a consistent partner who is willing to engage in sexual activity more than twice per month during the study.

Exclusion Criteria:

* History of bone marrow disorders
* Serum AST/ALT \> 3 X upper limit of normal or Creatinine \> 1.5 X upper limit of normal
* History of hypersensitivity against a gentamycin
* Severe cardiovascular disease(angina, arrhythmia, cardiac failure, stroke), kidney failure, respiratory failure
* Positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and syphilis test
* Positive for PSA or CEA or AFP (Carcinoembryonic antigen), history of cancer in the last five years (except Prostatic cancer) Uncontrolled hypertension or hypotension (systolic blood pressure \> 170 or \< 90 mm Hg, diastolic pressure \> 100 or \< 50 mm Hg)
* HbA1c exhibit greater than 10%
* Men on anticoagulant treatment
* Have a severe infectious disease
* Testosterone level is less than 200ng/dl
* Have a penile implant or willing to it
* Patients with morphological changes of the penis
* Patient's partner is trying to conceive during the trial period
* Unwilling to participate in the study
* Participating in other clinical trials in the past 30 days
* Unable to compliance with protocol
* Inappropriate patients to participate in the study according to the investigator

Primary outcomes:
measure: Number and severity of adverse events
timeFrame: 12month
Secondary outcomes:
measure: Change From Baseline in the International Index of Erectile Function(IIEF)
timeFrame: month 1, 3, 6, 9 and 12
measure: Penile Doppler Sonography, PDS
timeFrame: month 6, 12
measure: Change From Baseline in Sexual Encounter Profile (SEP) Question 2
timeFrame: month 1, 3, 6, 9 and 12
measure: Global Assessment Question (GAQ)
timeFrame: month 1, 3, 6, 9 and 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
Study officials:
affiliation: AIDS Malignancy Consortium
name: Chungsu Kim, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: You D, Jang MJ, Song G, Shin HC, Suh N, Kim YM, Ahn TY, Kim CS. Safety of autologous bone marrow-derived mesenchymal stem cells in erectile dysfunction: an open-label phase 1 clinical trial. Cytotherapy. 2021 Oct;23(10):931-938. doi: 10.1016/j.jcyt.2021.06.001. Epub 2021 Jul 27.