Autologous Bone Marrow Concentrate in Treatment of Erectile Dysfunction.
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|ClinicalTrials.gov Identifier: NCT03699943|
Recruitment Status : Completed
First Posted : October 9, 2018
Last Update Posted : September 6, 2019
|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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|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)|
|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|
Active Comparator: CaverStem 1.0 - Low
Intra-cavernosal injection of autologous bone marrow concentrate for the treatment of Erectile Dysfunction. low dose 30 cc
Active Comparator: CaverStem 1.0 - High
Intra-cavernosal injection of autologous bone marrow concentrate for the treatment of Erectile Dysfunction. high dose 60 cc
Active Comparator: Caverstem 2.0 - Clinical Registry
Intra-cavernosal injection of autologous bone marrow concentrate for the treatment of Erectile Dysfunction. 20 cc
- Improvement in erectile function as measured by total score in the International Index of Erectile Function [ Time Frame: 6 months ]IIEF-5 scale
- Rate of Adverse Events [ Time Frame: 6 months ]bruising, infection, pain
- Change in Doppler Measurements [ Time Frame: 6 months ]ml/s
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|
|Study Chair:||Alex Gershman||UCLA/Cedar|
|Study Director:||Jacob Rajfer||University of California, Los Angeles|