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

Erectile Dysfunction Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02087397
• Other study ID #: AD-US-ED-001
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: March 12, 2014
• Last updated: November 21, 2017
• Start date: March 2014
• Est. completion date: December 2017

Study information

• Verified date: November 2017
• Source: Ageless Regenerative Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

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

Biological:
• AD-SVF Cell Injection
Stem cell implantation will be performed using direct injection into the Corpus Cavernosum with local anesthesia

Locations

Country	Name	City	State
United States	Ageless Regenerative Institute LLC	Aventura	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ageless Regenerative Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants with Adverse Events		Baseline, 3 Months, and 6 Months
Primary	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	Baseline, 3 months, and 6 months
Secondary	Change from Baseline of Penile Doppler		Baseline and 6 moths
Secondary	Improvement in Phallometry Measures	Air Chamber Measurements/ Circumference Measurements	Baseline, 3 Months, and 6 Months