Trial record 6 of 61 for:    Open Studies | "Erectile Dysfunction"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Ageless Regenerative Institute
Sponsor:
Information provided by (Responsible Party):
Ageless Regenerative Institute
ClinicalTrials.gov Identifier:
NCT02087397
First received: March 12, 2014
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stem Cell (ASC) 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.

ASCs 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).


Condition Intervention Phase
Erectile Dysfunction
Other: Liposuction
Other: Stem Cell Injection
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Ageless Regenerative Institute:

Primary Outcome Measures:
  • Change from Baseline in Schramek's Grade [ Time Frame: Baseline, 3 months, and 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 6 moths ] [ Designated as safety issue: No ]
  • Improvement in Phallometry Measures [ Time Frame: Baseline, 3 Months, and 6 Months ] [ Designated as safety issue: No ]
    Air Chamber Measurements/ Circumference Measurements


Other Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: Baseline, 3 Months, and 6 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: March 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Stem Cell Injection
Non-Randomized
Other: Liposuction
Liposuction using aspiration syringe and tumescent local anesthesia
Other Name: Adipose Derived Stem Cells
Other: Stem Cell Injection
Stem cell implantation will be performed using direct injection into the Corpus Cavernosum with local anesthesia
Other Name: Stem Cell Injection

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02087397

Contacts
Contact: Melissa Mayans 305-933-2988 clinicaltrials@agelessinstitute.com

Locations
United States, Florida
Ageless Institute Recruiting
Aventura, Florida, United States, 33180
Contact: Melissa Mayans    305-933-2988    clinicaltrials@agelessinstitute.com   
Principal Investigator: Sharon McQuillan, MD         
Sponsors and Collaborators
Ageless Regenerative Institute
Investigators
Principal Investigator: Sharon McQuillan, MD Ageless Regenerative Institute
  More Information

No publications provided

Responsible Party: Ageless Regenerative Institute
ClinicalTrials.gov Identifier: NCT02087397     History of Changes
Other Study ID Numbers: ADI-US-ED-001
Study First Received: March 12, 2014
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ageless Regenerative Institute:
Stem Cell
Erectile Dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014