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

Sponsor
Ageless Regenerative Institute (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02087397
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
45
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Liposuction
  • Biological: AD-SVF Cell Injection
 Phase 1/Phase 2

Detailed Description

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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.
Study Start Date :
Mar 1, 2014
Anticipated Primary Completion Date :
Nov 1, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: AD-SVF Cell Injection

Other: Liposuction
Liposuction using aspiration syringe and tumescent local anesthesia
Other Names:
  • Lipoaspiration

    • Biological: AD-SVF Cell Injection
    Stem cell implantation will be performed using direct injection into the Corpus Cavernosum with local anesthesia
    Other Names:
  • Adipose derived Stromal Vascular Fraction Cell Injection

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Schramek's Grade [Baseline, 3 months, and 6 months]

      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

    Secondary Outcome Measures

    1. Change from Baseline of Penile Doppler [Baseline and 6 moths]

    2. Improvement in Phallometry Measures [Baseline, 3 Months, and 6 Months]

      Air Chamber Measurements/ Circumference Measurements

    Other Outcome Measures

    1. Number of Participants with Adverse Events [Baseline, 3 Months, and 6 Months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ageless Regenerative Institute LLC Aventura Florida United States 33180

    Sponsors and Collaborators

    • Ageless Regenerative Institute

    Investigators

    • Principal Investigator: Sharon McQuillan, MD, Ageless Regenerative Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ageless Regenerative Institute
    ClinicalTrials.gov Identifier:
    NCT02087397
    Other Study ID Numbers:
    • AD-US-ED-001
    First Posted:
    Mar 14, 2014
    Last Update Posted:
    Nov 24, 2017
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Ageless Regenerative Institute
    Stem Cell
    Erectile Dysfunction
    Additional relevant MeSH terms:
    Erectile Dysfunction

    Study Results

    No Results Posted as of Nov 24, 2017