Autologous Bone Marrow Concentrate in Treatment of Erectile Dysfunction.

Completed · Not applicable

Conditions studied: Erectile Dysfunction

In brief

This study assessed the safety and efficacy of autologous bone marrow concentrate and injected intra-cavernously into patients with erectile dysfunction (ED). Specifically, this study will evaluate ED treatment \>18 year old men, a demographic where the etiology of ED is attributable primarily to the loss of corporal smooth muscle in the penis. Study endpoints will evaluate the safety and efficacy of intracavernosal bone marrow concentrate administration for treating ED patients.

Key facts

Study ID

NCT03699943

Run by

Creative Medical Health, Inc.

People needed

40

Starts

2015-12-08

Expected to finish

2019-08-31

Last updated by the study team

2019-09-06

Who can join

Age: 18 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Chronic organic ED duration at least 0.5 years
• Diagnosis of ED based on Doppler Ultrasound and/or dynamic infusion cavernosonometry.
• Baseline International Index of Erectile Function (IIEF-5) score of < 21
• Oral medications and intracavernous pharmacological approaches have been deemed ineffective, contraindicated or cannot be tolerated.
• Concurrently undergoing treatment with testosterone.
• Willing to forego any other treatments for ED over the course of the study.

You may not qualify if…

• Subjects using any medications/drugs with known effects on erectile function within 4 weeks of the study period, including certain antidepressants, antihistamines, diuretics, and beta-blockers.
• Subjects using herbal remedies for addressing erectile dysfunction within one month of study initiation.
• Subjects with penile prosthesis or other urinary prosthesis.
• Subjects with penile anatomical deformities (e.g. Peyronie's disease) or history of priapism.
• Previous penile surgeries for erectile dysfunction, premature ejaculation or penile enlargement.
• Diagnosis of psychogenic ED as determined by nocturnal tumenscence testing.
• Presenting with uncontrolled or severe disease, including cardiovascular disease, diabetes, liver disease.
• Uncontrolled hypertension or hypotension (systolic blood pressure > 170 or < 90 mm Hg, and diastolic blood pressure > 100 or < 50 mm Hg)
• Suffered a cardiovascular event within 6 months prior to study initiation.
• Current or previous malignancy other than non-melanoma skin cancer (successfully treated or treatable by curative excision or other local curative therapy).
• Diagnosis of a systemic autoimmune disorder.
• Receiving immunosuppressant medications.

Where it is running

• Harbor - UCLA Medical Center — Torrance, California, United States

Full record on ClinicalTrials.gov

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