Autologous Bone Marrow Concentrate in Treatment of Erectile Dysfunction.

NCT03699943 | Completed DMC

• 1 other identifier: 21511-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (2)

• Improvement in erectile function as measured by total score in the International Index of Erectile Function

  IIEF-5 scale

  6 months

• Rate of Adverse Events

  bruising, infection, pain

  6 months

Secondary Outcomes (1)

• Change in Doppler Measurements

  6 months

Study Arms (3)

CaverStem 1.0 - Low

ACTIVE COMPARATOR

Intra-cavernosal injection of autologous bone marrow concentrate for the treatment of Erectile Dysfunction. low dose 30 cc

Procedure: CaverStem

CaverStem 1.0 - High

ACTIVE COMPARATOR

Intra-cavernosal injection of autologous bone marrow concentrate for the treatment of Erectile Dysfunction. high dose 60 cc

Procedure: CaverStem

Caverstem 2.0 - Clinical Registry

ACTIVE COMPARATOR

Intra-cavernosal injection of autologous bone marrow concentrate for the treatment of Erectile Dysfunction. 20 cc

Procedure: CaverStem

Interventions

CaverStem PROCEDURE

CaverStem 1.0 - High; CaverStem 1.0 - Low; Caverstem 2.0 - Clinical Registry

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Creative Medical Health, Inc.: lead

Study Sites (1)

Harbor - UCLA Medical Center

Torrance, California, 90502, United States

Location

Related Publications (1)

• 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.

  PMID: 31937310 DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

• Alex Gershman

  UCLA/Cedar

  STUDY CHAIR

• Jacob Rajfer

  University of California, Los Angeles

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 12, 2015
• First Posted: October 9, 2018
• Study Start: December 8, 2015
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2019
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: 1 year

Locations

US (1)