Erectile Dysfunction Clinical Trial
Official title:
Feasibility Study of Intra-cavernosal Administration of Non-Expanded Autologous Bone Marrow Concentrate in Treatment of Erectile Dysfunction.
Verified date | September 2019 |
Source | Creative Medical Health, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | August 31, 2019 |
Est. primary completion date | August 31, 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Chronic organic ED duration at least 0.5 years 2. Diagnosis of ED based on Doppler Ultrasound and/or dynamic infusion cavernosonometry. 3. Baseline International Index of Erectile Function (IIEF-5) score of < 21 4. Oral medications and intracavernous pharmacological approaches have been deemed ineffective, contraindicated or cannot be tolerated. 5. Concurrently undergoing treatment with testosterone. 6. Willing to forego any other treatments for ED over the course of the study. Exclusion Criteria: 1. 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. 2. Subjects using herbal remedies for addressing erectile dysfunction within one month of study initiation. 3. Subjects with penile prosthesis or other urinary prosthesis. 4. Subjects with penile anatomical deformities (e.g. Peyronie's disease) or history of priapism. 5. Previous penile surgeries for erectile dysfunction, premature ejaculation or penile enlargement. 6. Diagnosis of psychogenic ED as determined by nocturnal tumenscence testing. 7. Presenting with uncontrolled or severe disease, including cardiovascular disease, diabetes, liver disease. 8. Uncontrolled hypertension or hypotension (systolic blood pressure > 170 or < 90 mm Hg, and diastolic blood pressure > 100 or < 50 mm Hg) 9. Suffered a cardiovascular event within 6 months prior to study initiation. 10. Current or previous malignancy other than non-melanoma skin cancer (successfully treated or treatable by curative excision or other local curative therapy). 11. Diagnosis of a systemic autoimmune disorder. 12. Receiving immunosuppressant medications. |
Country | Name | City | State |
---|---|---|---|
United States | Harbor - UCLA Medical Center | Torrance | California |
Lead Sponsor | Collaborator |
---|---|
Creative Medical Health, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in erectile function as measured by total score in the International Index of Erectile Function | IIEF-5 scale | 6 months | |
Primary | Rate of Adverse Events | bruising, infection, pain | 6 months | |
Secondary | Change in Doppler Measurements | ml/s | 6 months |
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