Autologous Bone Marrow Concentrate in Treatment of Erectile Dysfunction.

• ClinicalTrials.gov Identifier: NCT03699943
• Recruitment Status: Completed
• First Posted: October 9, 2018
• Last Update Posted: September 6, 2019
• Sponsor: Creative Medical Health, Inc.
• Information provided by (Responsible Party): Creative Medical Health, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Erectile Dysfunction	Procedure: CaverStem	Not Applicable

Detailed Description:

Erectile dysfunction (ED) is characterized by abnormalities of the vascular system; most commonly, venous leakage (or veno-occlusive dysfunction) resulting from loss of integrity of the surrounding corporal smooth muscle. In the penile vascular system, the corporal smooth muscle is responsible for trapping the blood delivered to the corpora cavernosa via the arterial system.

Bone marrow is enriched for cells with regenerative potential, including mesenchymal stem cells, which accelerate healing of damaged tissue. The possibility of using bone marrow cells in the treatment of ED is enticing since stem/progenitor cell populations are known to secrete various growth factors, possess anti-inflammatory activities, and can differentiate into cells of the penile architecture.

This study will evaluate safety and efficacy of autologous bone marrow concentrate generated by a closed system device and injected intra-cavernously in 40 patients aged > 18 years of age diagnosed with erectile dysfunction with low dose 30 cc (20 patients) or high dose 60 cc (20 patients). Safety and efficacy will be evaluated at baseline (prior to treatment) and at 1,3,6 and 12-month follow up visits. The study will determine whether injection of bone marrow cells intra-cavernously is a clinically feasible, safe and reproducible approach for treating erectile dysfunction. A clinical registry will also be enrolling treating the same patient population (100 patients (20 cc)).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Caverstem 1.0 - Low dose - 30 cc - 20 patients Caverstem 1.0 - High dose - 60 cc - 20 patients Caverstem 2.0 - 20 cc - 100 patients
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Feasibility Study of Intra-cavernosal Administration of Non-Expanded Autologous Bone Marrow Concentrate in Treatment of Erectile Dysfunction.
• Actual Study Start Date: December 8, 2015
• Actual Primary Completion Date: August 31, 2018
• Actual Study Completion Date: August 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: CaverStem 1.0 - Low; Intra-cavernosal injection of autologous bone marrow concentrate for the treatment of Erectile Dysfunction. low dose 30 cc	Procedure: CaverStem
Active Comparator: CaverStem 1.0 - High; Intra-cavernosal injection of autologous bone marrow concentrate for the treatment of Erectile Dysfunction. high dose 60 cc	Procedure: CaverStem
Active Comparator: Caverstem 2.0 - Clinical Registry; Intra-cavernosal injection of autologous bone marrow concentrate for the treatment of Erectile Dysfunction. 20 cc	Procedure: CaverStem

Outcome Measures

Primary Outcome Measures :

1. Improvement in erectile function as measured by total score in the International Index of Erectile Function [ Time Frame: 6 months ]
   IIEF-5 scale
2. Rate of Adverse Events [ Time Frame: 6 months ]
   bruising, infection, pain

Secondary Outcome Measures :

1. Change in Doppler Measurements [ Time Frame: 6 months ]
   ml/s

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, California

Harbor - UCLA Medical Center

Torrance, California, United States, 90502

Sponsors and Collaborators

Creative Medical Health, Inc.

Investigators

• Study Chair: Alex Gershman; UCLA/Cedar
• Study Director: Jacob Rajfer; University of California, Los Angeles

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bieri M, Said E, Antonini G, Dickerson D, Tuma J, Bartlett CE, Patel AN, Gershman A. Phase I and registry study of autologous bone marrow concentrate evaluated in PDE5 inhibitor refractory erectile dysfunction. J Transl Med. 2020 Jan 14;18(1):24. doi: 10.1186/s12967-019-02195-w.

• Responsible Party: Creative Medical Health, Inc.
• ClinicalTrials.gov Identifier: NCT03699943
• Other Study ID Numbers: 21511-01
• First Posted: October 9, 2018
• Last Update Posted: September 6, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Data will be shared among other investigators through secure clinical registry.
• Supporting Materials: Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: 1 year

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Erectile Dysfunction; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders