Erectile Dysfunction Clinical Trial
Official title:
Feasibility Study of Intra-cavernosal Administration of Non-Expanded Autologous Bone Marrow Concentrate in Treatment of Erectile Dysfunction.
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.
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)).
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