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clinical-trials

TRIAL SYNOPSIS

STUDY TYPE:

Interventional

TITLE OF STUDY:

Feasibility Study of Intracaversnosal Administration of Non-Expanded Autologous Bone Marrow Cells in Treatment of Erectile Dysfunction

STUDY CENTERS:

Single site; LA Biomed, Harbor-UCLA Medical Center

NUMBER OF SUBJECTS:

20 Patients

STUDY DURATION:

Study will be concluded 12 months after entry of each patient into the study.

STUDY OBJECTIVE:

To evaluate safety and efficacy of autologous bone marrow mononuclear cells concentrated using a closed-system device, the Arteriocyte Magellan® device, and injected intra-cavernously in 20 patients aged 18 to 40 years of age diagnosed with erectile dysfunction. Safety will be determined based on device- and procedure-associated adverse events and blood chemistry measurements at baseline vs. follow up visits at one, three, six, and twelve months post-treatment. Efficacy will be evaluated at baseline and follow up visits by Doppler ultrasound, dynamic infusion cavernosometry, and blood work. The study will determine whether injection of bone marrow cells intra-cavernously is a clinically feasible therapeutic approach for treating erectile dysfunction.

STUDY RATIONALE:

Bone marrow is enriched for cells with regenerative potential, including mesenchymal stem cells (MSC), 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. While the therapeutic activities of MSC have been established in animal models of erectile dysfunction [1-8], this study will be the first to examine the utility of intra-cavernosal injection of stem cells in a clinical setting.

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 [9]. 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 [9, 10].
Bone marrow mononuclear cells can be extracted and concentrated in FDA-approved closed system devices and are already being used under the practice of medicine for a variety of indications. Therefore, we are seeking to explore the safety and feasibility of bone marrow cells harvested using Arteriocyte’s Magellan® device and administered intracavernously to patients with ED.

STUDY ENDPOINTS:

Primary Outcome Measures:
• Improvement in erectile function as measured by total score in the International Index of Erectile Function [Time frame: Baseline to 6 months]
• Change in Doppler Ultrasound (papaverine induced color duplex Doppler) for evaluating blood flow [Time frame: Baseline to 6 months]
• Change in dynamic infusion cavernosometry that measures veno-occlusive pressure [Time frame: Baseline to 6 months]
• Adverse events [Time frame: Baseline to 12 months]
Secondary Outcome Measures:
• Improvement in erectile function as measured by total score in the International Index of Erectile Function [Time frame: Baseline to 12 months]