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
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction||Procedure: CaverStem||Not Applicable|
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|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Low dose - 30 cc High dose - 60 cc|
|Masking:||Single (Outcomes Assessor)|
|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|
Active Comparator: CaverStem - A
Intra-cavernosal injection of autologous bone marrow stem cells for the treatment of Erectile Dysfunction. low dose 30 cc
Active Comparator: CaverStem - B
Intra-cavernosal injection of autologous bone marrow stem cells for the treatment of Erectile Dysfunction. high dose 60 cc
- Improvement in erectile function as measured by total score in the International Index of Erectile Function [ Time Frame: Baseline 6 months ]
- Change in Doppler Ultrasound [ Time Frame: Baseline 6 months ]
- Change in dynamic infusion cavernosometry [ Time Frame: Baseline 6 months ]
- Adverse events [ Time Frame: Baseline 12 months ]
- Improvement in erectile function as measured by total score in the International Index of Erectile Function [ Time Frame: Baseline 12 months ]
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
|United States, California|
|Harbor - UCLA Medical Center|
|Torrance, California, United States, 90502|
|Principal Investigator:||Jacob Rajfer, MD||University of California, Los Angeles|