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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: NCT00518401
Recruitment Status : Completed
First Posted : August 20, 2007
Last Update Posted : April 28, 2011
Information provided by:
TCA Cellular Therapy

Brief Summary:

The purpose of this research study is to determine 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 the severely diseased ischemic limb (leg). In this study the safe use of this combination of stem cells and its effects on making new blood vessels will be evaluated.

Limb Ischemia (LI) is a severe obstruction of the arteries which seriously decreases 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 the pain and increase blood flow to improve symptoms or save the leg or 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 vessels 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 appropriate blood supply to the leg.

Patients eligible to participate in this study are those suffering from 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 the diseased leg. Clinical studies to evaluate if the transplant works and is safe will be performed up to 1 year after cell transplant.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Peripheral Vascular Disease Biological: Mesendo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of A Combination Stem Cell Therapy is Safe and Feasible in the Development of Mature Stable Vessels in Ischemic Limbs
Study Start Date : June 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : October 2009

Intervention Details:
  • Biological: Mesendo
    Intramuscular injection of 0.5 cc per site of the combination stem cell mixture in approximately 40 different ischemic sites of the gastrocnemius area of the calf.

Primary Outcome Measures :
  1. Safety [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 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 £ 0.6 in the index lower extremity in two consecutive examinations done at least 1 week apart.
  • Limb ischemia with resting ischemic pain and/or non-healing ulcers.
  • 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.
  • Pregnant women or women planning to become pregnant.
  • 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): NCT00518401

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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, MD, FACC TCA Cellular Therapy
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Responsible Party: Gabriel P. Lasala, MD, TCA Cellular Therapy, LLC Identifier: NCT00518401    
Other Study ID Numbers: 2007-01-I
First Posted: August 20, 2007    Key Record Dates
Last Update Posted: April 28, 2011
Last Verified: February 2010
Keywords provided by TCA Cellular Therapy:
A hypoperfusion of the blood through a leg
Stem cells
Stem cell transplantation
Stem cell autologous transplantation
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Arterial Occlusive Diseases