Phase II Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia (MESENDO)
The purpose of this research study is to compare in patients with double-sided claudication if the transplant of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in one of the severly diseased ischemic limbs(legs)versus the control limb that receives a placebo product.
Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decrease blood flow to the extremities (mainly feet and legs) and has progressed to the point of severe pain and even skin ulcers or sores.
LI needs comprehensive treatment since the condition will not improve on its own. The overall goal of treatment is to reduce pain and increase blood flow to improve symptoms or save the leg and feet. In many cases, current options for treatment including medications, surgery or endovascular procedures have not been successful.
In the last few years, investigators have explored therapies aimed to increase blood flow to the ischemic vessel by transplanting cells that will promote the development of new vessels in the diseased leg.
The study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. The lack of any of these components will produce vessels which are immature and unable to provide appropriated blood supply to the leg.
Patients eligible to participate in the this study are those suffering from double-sided claudication with poor circulation or severe leg blockages, which are not candidates for surgical procedures.
Once the mixture of stem cells is prepared and the patient's bone marrow is ready, cells will be transplanted into the calf muscle of one the the diseased legs while the other diseased leg will receive the placebo. Clinical study to evaluate and compare the efficacy of the stem cell transplant will be performed for six months post cell transplant.
Critical Limb Ischemia
Severe Leg Ischemia
Peripheral Artery Disease
Peripheral Vascular Disease
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Phase II Safety/Efficacy Study of A Combination Stem Cell Therapy That Develops Mature Stable Vessel Formation in Ischemic Limbs|
- Enhancement of vessel formation accessed by Nuclear Perfusion Scan in critical limb ischemia. [ Time Frame: 4 months ] [ Designated as safety issue: No ]
- Changes in resting leg pain identified by a Visual Analog Scale and patient safety [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2008|
|Study Completion Date:||September 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
All subjects will receive active treatment in a blinded fashion in the left or right lower limb. The opposite lower limb will receive placebo.
40 subcutaneous injections of biological product
Placebo Comparator: placebo
All subjects will receive placebo injections in a blinded fashion in the left or right lower limb. The opposite lower limb will receive active stem cell infusion
40 subcutaneous injections of placebo
|United States, Louisiana|
|TCA Cellular Therapy|
|Covington, Louisiana, United States, 70433|
|Principal Investigator:||Gabriel P Lasala, M.D.||TCA Cellular Therapy, LLC|