Combination Stem Cell Therapy for the Treatment of Severe Leg Ischemia - Full Text View

Sponsor:	TCA Cellular Therapy
Information provided by:	TCA Cellular Therapy
ClinicalTrials.gov Identifier:	NCT00518401

Purpose

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	Intervention	Phase
Critical Limb Ischemia Peripheral Vascular Disease	Biological: Mesendo	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Peripheral Arterial Disease Vascular Diseases

U.S. FDA Resources

Further study details as provided by TCA Cellular Therapy:

Primary Outcome Measures:

Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	10
Study Start Date:	June 2007
Study Completion Date:	October 2009
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	18 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 £ 0.6 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00518401

Locations

United States, Louisiana
TCA Cellular Therapy
Covington, Louisiana, United States, 70433

Sponsors and Collaborators

TCA Cellular Therapy

Investigators

Principal Investigator:

Gabriel P. Lasala, MD, FACC

TCA Cellular Therapy

More Information

No publications provided

Responsible Party:	Gabriel P. Lasala, MD, TCA Cellular Therapy, LLC
ClinicalTrials.gov Identifier:	NCT00518401 History of Changes
Other Study ID Numbers:	2007-01-I
Study First Received:	August 16, 2007
Last Updated:	April 27, 2011
Health Authority:	United States: Food and Drug Administration

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:

Ischemia
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes

Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on February 12, 2012