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

NCT ID: NCT02087397

Last Updated: 2017-11-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-12-31

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).

Conditions

Erectile Dysfunction

Keywords

Stem Cell; Erectile Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AD-SVF Cell Injection

Group Type: EXPERIMENTAL

Liposuction

Intervention Type: OTHER

Liposuction using aspiration syringe and tumescent local anesthesia

AD-SVF Cell Injection

Intervention Type: BIOLOGICAL

Stem cell implantation will be performed using direct injection into the Corpus Cavernosum with local anesthesia

Interventions

Liposuction

Liposuction using aspiration syringe and tumescent local anesthesia

Intervention Type: OTHER

AD-SVF Cell Injection

Stem cell implantation will be performed using direct injection into the Corpus Cavernosum with local anesthesia

Intervention Type: BIOLOGICAL

Other Intervention Names

Lipoaspiration; Adipose derived Stromal Vascular Fraction Cell Injection

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ageless Regenerative Institute

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon McQuillan, MD

Role: PRINCIPAL_INVESTIGATOR

Ageless Regenerative Institute

Locations

Ageless Regenerative Institute LLC

Aventura, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25974235 (View on PubMed)

Other Identifiers

AD-US-ED-001

Identifier Type: -

Identifier Source: org_study_id