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company dissolved
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AD-SVF Cell Injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposuction | Other | Liposuction using aspiration syringe and tumescent local anesthesia |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | Baseline, 3 Months, and 6 Months |
Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Sharon McQuillan, MD | Ageless Regenerative Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ageless Regenerative Institute LLC | Aventura | Florida | 33180 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25974235 | Derived | Khera M, Albersen M, Mulhall JP. Mesenchymal stem cell therapy for the treatment of erectile dysfunction. J Sex Med. 2015 May;12(5):1105-6. doi: 10.1111/jsm.12871. No abstract available. |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| D015187 | Lipectomy |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
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| AD-SVF Cell Injection | Biological | Stem cell implantation will be performed using direct injection into the Corpus Cavernosum with local anesthesia |
|
|
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D000073319 |
| Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |