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Phase II Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia (MESENDO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00721006
Recruitment Status : Completed
First Posted : July 23, 2008
Last Update Posted : May 9, 2014
Information provided by (Responsible Party):
TCA Cellular Therapy

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Severe Leg Ischemia Peripheral Artery Disease Peripheral Vascular Disease Biological: MESENDO Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : June 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : September 2010

Arm Intervention/treatment
Experimental: MESENDO
All subjects will receive active treatment in a blinded fashion in the left or right lower limb. The opposite lower limb will receive placebo.
Biological: MESENDO
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
Biological: Placebo
40 subcutaneous injections of placebo

Primary Outcome Measures :
  1. Enhancement of vessel formation accessed by Nuclear Perfusion Scan in critical limb ischemia. [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Changes in resting leg pain identified by a Visual Analog Scale and patient safety [ Time Frame: 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males or females older than 18 years of age.
  • Limb ischemia with ABI of < 0.7 in the index lower extremity in two consecutive examinations done at least 1 week apart.
  • Limb ischemia with resting ischemic pain and/or claudication at 100 meters and/or non-healing ulcers.
  • Claudication
  • Patients not considered candidates for surgical or percutaneous revascularization, due to poor target vessels, inability to cross total occlusions, or a morbidity which precludes general anesthesia.

Exclusion Criteria:

  • Inability to provide informed consent.
  • Previous angiogenic therapy.
  • Known sensitivity to gentamycin and/or amphotericin B.
  • Use or expected use of antineoplastic drugs.
  • Any illness, which might affect the patient's survival after enrollment in the protocol.
  • Any illness or significant laboratory abnormality, which in the investigator's judgment will interfere with the patient's ability to comply with the protocol, compromise the patient's safety, or interfere with the interpretation of the study results.
  • No evidence of acute infection
  • WBC > 15000.
  • WBC < 4000.
  • Serum Creatinine > 3.0 mg/dL in patients who are not in hemodialysis.
  • Pregnant women or women planning to become pregnant or unwilling to use appropriate birth control methods before and 2 months after cell infusion.
  • Recent myocardial infarction within 3 months prior to screening.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00721006

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United States, Louisiana
TCA Cellular Therapy
Covington, Louisiana, United States, 70433
Sponsors and Collaborators
TCA Cellular Therapy
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Principal Investigator: Gabriel P Lasala, M.D. TCA Cellular Therapy, LLC
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: TCA Cellular Therapy Identifier: NCT00721006    
Other Study ID Numbers: 2008-01-II
First Posted: July 23, 2008    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: September 2010
Keywords provided by TCA Cellular Therapy:
peripheral artery disease
peripheral vascular disease
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Pathologic Processes
Cardiovascular Diseases
Arterial Occlusive Diseases