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

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Erectile Dysfunction

In brief

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.

Key facts

Study ID

NCT02087397

Run by

Ageless Regenerative Institute

People needed

0

Starts

2014-03-01

Expected to finish

2017-12-01

Last updated by the study team

2017-11-24

Who can join

Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Ageless Regenerative Institute LLC — Aventura, Florida, United States

Full record on ClinicalTrials.gov

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