Back to results

Autologous Bone Marrow Concentrate in Treatment of Erectile Dysfunction.

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CaverStem

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Harbor - UCLA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

CaverStem 1.0 - Low

CaverStem 1.0 - High

Caverstem 2.0 - Clinical Registry

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

IIEF-5 scale

Rate of Adverse Events

bruising, infection, pain

Secondary Outcome Measures

Change in Doppler Measurements

ml/s

Full Information

NCT ID

NCT03699943

First Posted

December 12, 2015

Last Updated

September 4, 2019

Sponsor

Creative Medical Health, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03699943

Brief Title

Autologous Bone Marrow Concentrate in Treatment of Erectile Dysfunction.

Official Title

Feasibility Study of Intra-cavernosal Administration of Non-Expanded Autologous Bone Marrow Concentrate in Treatment of Erectile Dysfunction.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

December 8, 2015 (Actual)

Primary Completion Date

August 31, 2018 (Actual)

Study Completion Date

August 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Creative Medical Health, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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)).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

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

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CaverStem 1.0 - Low

Arm Type

Active Comparator

Arm Description

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

Arm Title

CaverStem 1.0 - High

Arm Type

Active Comparator

Arm Description

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

Arm Title

Caverstem 2.0 - Clinical Registry

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

CaverStem

Primary Outcome Measure Information:

Title

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

Description

IIEF-5 scale

Time Frame

6 months

Title

Rate of Adverse Events

Description

bruising, infection, pain

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Change in Doppler Measurements

Description

ml/s

Time Frame

6 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alex Gershman

Organizational Affiliation

UCLA/Cedar

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jacob Rajfer

Organizational Affiliation

University of California, Los Angeles

Official's Role

Study Director

Facility Information:

Facility Name

Harbor - UCLA Medical Center

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data will be shared among other investigators through secure clinical registry.

IPD Sharing Time Frame

1 year

Citations:

PubMed Identifier

31937310

Citation

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.

Results Reference

derived

Learn more about this trial

Autologous Bone Marrow Concentrate in Treatment of Erectile Dysfunction.

We'll reach out to this number within 24 hrs