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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
TCA Cellular Therapy
ClinicalTrials.gov Identifier:
NCT00721006
First received: July 21, 2008
Last updated: May 7, 2014
Last verified: September 2010
  Purpose

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 Intervention Phase
Critical Limb Ischemia
Severe Leg Ischemia
Peripheral Artery Disease
Peripheral Vascular Disease
Biological: MESENDO
Biological: Placebo
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by TCA Cellular Therapy:

Primary Outcome Measures:
  • Enhancement of vessel formation accessed by Nuclear Perfusion Scan in critical limb ischemia. [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in resting leg pain identified by a Visual Analog Scale and patient safety [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: June 2008
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721006

Locations
United States, Louisiana
TCA Cellular Therapy
Covington, Louisiana, United States, 70433
Sponsors and Collaborators
TCA Cellular Therapy
Investigators
Principal Investigator: Gabriel P Lasala, M.D. TCA Cellular Therapy, LLC
  More Information

No publications provided by TCA Cellular Therapy

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: TCA Cellular Therapy
ClinicalTrials.gov Identifier: NCT00721006     History of Changes
Other Study ID Numbers: 2008-01-II
Study First Received: July 21, 2008
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by TCA Cellular Therapy:
peripheral artery disease
peripheral vascular disease
PAD
PVD

Additional relevant MeSH terms:
Ischemia
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on July 31, 2014