search
Back to results

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

Primary Purpose

Erectile Dysfunction

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Liposuction
AD-SVF Cell Injection
Sponsored by
Ageless Regenerative Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Stem Cell, Erectile Dysfunction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ageless Regenerative Institute LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AD-SVF Cell Injection

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline of Penile Doppler
Improvement in Phallometry Measures
Air Chamber Measurements/ Circumference Measurements

Full Information

First Posted
March 12, 2014
Last Updated
November 21, 2017
Sponsor
Ageless Regenerative Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT02087397
Brief Title
Autologous Adipose-Derived Stromal Cells Delivered Into the Corpus Cavernous in Patients With Erectile Dysfunction
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 Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
company dissolved
Study Start Date
March 2014 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ageless Regenerative Institute

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Stem Cell, Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AD-SVF Cell Injection
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Liposuction
Other Intervention Name(s)
Lipoaspiration
Intervention Description
Liposuction using aspiration syringe and tumescent local anesthesia
Intervention Type
Biological
Intervention Name(s)
AD-SVF Cell Injection
Other Intervention Name(s)
Adipose derived Stromal Vascular Fraction Cell Injection
Intervention Description
Stem cell implantation will be performed using direct injection into the Corpus Cavernosum with local anesthesia
Primary Outcome Measure Information:
Title
Change from Baseline in Schramek's Grade
Description
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
Time Frame
Baseline, 3 months, and 6 months
Secondary Outcome Measure Information:
Title
Change from Baseline of Penile Doppler
Time Frame
Baseline and 6 moths
Title
Improvement in Phallometry Measures
Description
Air Chamber Measurements/ Circumference Measurements
Time Frame
Baseline, 3 Months, and 6 Months
Other Pre-specified Outcome Measures:
Title
Number of Participants with Adverse Events
Time Frame
Baseline, 3 Months, and 6 Months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon McQuillan, MD
Organizational Affiliation
Ageless Regenerative Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ageless Regenerative Institute LLC
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25974235
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs