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Autologous Bone Marrow Cells in Treatment of Erectile Dysfunction.

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

Brief Summary:
This study assessed the safety and efficacy of autologous bone marrow mononuclear cells and injected intra-cavernously into patients with erectile dysfunction (ED). Specifically, this study will evaluate ED treatment in young 18-40 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 efficacy of intracavernosal stem cell administration for ameliorating the veno-occlusive dysfunction in 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. In men who develop ED at an early age, loss of smooth muscle mass, rather than arterial dysfunction, is believed to be the major culprit in the inability to maintain or sustain erections.

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 mononuclear cells concentrated by a closed system device and injected intra-cavernously in 20 patients aged 18 to 40 years of age diagnosed with erectile dysfunction with low dose 30 cc or high dose 60 cc. 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Low dose - 30 cc High dose - 60 cc
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feasibility Study of Intra-cavernosal Administration of Non-Expanded Autologous Bone Marrow Cells 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, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CaverStem - A
Intra-cavernosal injection of autologous bone marrow stem cells for the treatment of Erectile Dysfunction. low dose 30 cc
Procedure: CaverStem
Active Comparator: CaverStem - B
Intra-cavernosal injection of autologous bone marrow stem cells for the treatment of Erectile Dysfunction. high dose 60 cc
Procedure: CaverStem



Primary Outcome Measures :
  1. Improvement in erectile function as measured by total score in the International Index of Erectile Function [ Time Frame: Baseline 6 months ]
  2. Change in Doppler Ultrasound [ Time Frame: Baseline 6 months ]
  3. Change in dynamic infusion cavernosometry [ Time Frame: Baseline 6 months ]
  4. Adverse events [ Time Frame: Baseline 12 months ]

Secondary Outcome Measures :
  1. Improvement in erectile function as measured by total score in the International Index of Erectile Function [ Time Frame: Baseline 12 months ]


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Ages Eligible for Study:   18 Years to 40 Years   (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) score of < 26
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699943


Locations
United States, California
Harbor - UCLA Medical Center
Torrance, California, United States, 90502
Sponsors and Collaborators
Creative Medical Health, Inc.
Investigators
Principal Investigator: Jacob Rajfer, MD University of California, Los Angeles

Responsible Party: Creative Medical Health, Inc.
ClinicalTrials.gov Identifier: NCT03699943     History of Changes
Other Study ID Numbers: 21511-01
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: December 2015
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
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders