Autologous Adipose-Derived Stromal Cells Delivered Into the Corpus Cavernous in Patients With Erectile Dysfunction

Study Overview
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Brief Summary
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This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stromal Vascular Fraction cells (AD-SVF) implantation delivered into the corpus cavernous in patients with Erectile Dysfunction. The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed Erectile Dysfunction.

Detailed Description
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AD-SVF will be collected from the patient's adipose-derived tissue (body fat). Using local anesthesia, Liposuction will be performed to collect the adipose tissue specimen. The adipose tissue is then transferred to the laboratory for separation of the adipose tissue derived stem cells. In addition, peripheral blood will be collected for isolation of platelet rich plasma, which are then combined with the ASC's for direct injection to the Corpus Cavernosum (Penis).

Official Title
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An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Into the Corpus Cavernous in Patients With Erectile Dysfunction.

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Other: Liposuction
* Biological: AD-SVF Cell Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Males Age 18 and 80 years. Penile arterial insufficiency and or venous leakage (doppler) at the time o inclusion: PSV <25 cm/sec, PSV >25 cm/sec, EDV>5cm/sec, RI<0,75. Up to date on all age and gender appropriate cancer screening per American Cancer Society Exclusion Criteria Severe co-morbidities like cardiac insufficiency, congestive cardiac failure (NYHA ≥ III), malignancy, infection, sepsis and bed sores. Life expectancy < 6 months due to concomitant illnesses. Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study. Active infectious disease. Patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis will be evaluated by an expert as to patient eligibility based on the patient's infectious status Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or \ interfere with the interpretation of the study results Patients on chronic immunosuppressive transplant therapy Systolic blood pressure (supine) ≤90 mmHg or greater than 200mmHg Resting heart rate > 100 bpm; Active clinical infection within one week of enrollment. Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate. History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years. Unwilling and/or not able to give written informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AD-SVF Cell Injection<br> | Other: Liposuction<br>* Liposuction using aspiration syringe and tumescent local anesthesia<br>* Other names: Lipoaspiration;Biological: AD-SVF Cell Injection<br>* Stem cell implantation will be performed using direct injection into the Corpus Cavernosum with local anesthesia<br>* Other names: Adipose derived Stromal Vascular Fraction Cell Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Schramek's Grade | Schramek's grading system- penile rigidity Grade 1 - No erection Grade 2 - Slight Tumescence Grade 3 - Full volume without rigidity Grade 4 - Sufficient for sexual intercourse Grade 5 - Full erection | Baseline, 3 months, and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline of Penile Doppler |  | Baseline and 6 moths | 
| Improvement in Phallometry Measures | Air Chamber Measurements/ Circumference Measurements | Baseline, 3 Months, and 6 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stem Cell, Erectile Dysfunction