Autologous CD34+ Stem Cell Injection for Severe Intermittent Claudication (Leg Pain) - Full Text View

Sponsored by:	Losordo, Douglas, M.D.
Information provided by:	Losordo, Douglas, M.D.
ClinicalTrials.gov Identifier:	NCT00311805

Purpose

The goal of the study is to determine the safety and possible effectiveness of various doses of autologous (one's own) stem cells, delivered with a needle into the regions of the leg with poor blood flow in patients with blocked leg arteries that results in claudication (pain when walking). Stem cells are primitive cells produced by the bone marrow that can develop into blood cells or other types of cells. In addition to determining whether this new approach is safe, the diagnostic tests may offer preliminary insights into the usefulness of this approach for treating intermittent claudication - the condition where areas in the leg are lacking enough oxygen and blood flow to keep the leg muscle working well, causing pain and cramping upon walking.

This study is a double-blind, randomized study to compare CD34-positive stem cells versus a placebo agent (salt water solution known as normal saline).

The patient will have a 3:1 chance of their stem cells versus the placebo. Regardless of a patient receiving placebo or treatment, all patients will undergo all of the pre-treatment phases of this study, which includes the stem cell mobilization and apheresis procedure.

Condition	Intervention	Phase
Peripheral Artery Disease Severe Intermittent Claudication	Biological: Autologous Stem Cells (CD34+)	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Injection of Autologous CD34-Positive Stem Cells for Neovascularization and Symptom Relief in Patients With Severe Intermittent Claudication

Further study details as provided by Losordo, Douglas, M.D.:

Primary Outcome Measures:

Safety of Intramuscular administration of CD34-positive cells [ Time Frame: All ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Functional improvement [ Time Frame: Week 12, Month 6, Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	April 2006
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Biological: Autologous Stem Cells (CD34+) Intramuscular Injections
2: Active Comparator	Biological: Autologous Stem Cells (CD34+) Intramuscular Injections
3: Placebo Comparator	Biological: Autologous Stem Cells (CD34+) Intramuscular Injections

Eligibility

Ages Eligible for Study:	21 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males or females 21-80 years old
Patients with infra-inguinal atherosclerosis with a stenosis or occlusion of a major vessel in the affected limb(s) of one or more of the following arteries: superficial femoral, popliteal, or one or more infrapopliteal arteries, which is/are non-reconstructable.
Patients with symptoms of Severe Intermittent Claudication in at least 1 lower limb persisting for at least 6 months (Rutherford Class 3).
Patients who have a diagnosis of Peripheral Arterial Disease (PAD) in at least 1 lower limb secondary to atherosclerosis, for at least 6 months.

Exclusion Criteria:

Patients who have had successful aortic or lower extremity arterial surgery, angioplasty, or lumbar sympathectomy within 3 month preceding screening.
Patients with iliac disease amenable to revascularization.
Patients judged to be a suitable candidate for surgical or percutaneous revascularization in the limb in which treatment is proposed.
Patients with Critical Limb Ischemia (CLI), Rutherford Symptom Score of 4,5, or 6.
Patients in who arterial insufficiency in the lower extremity is the result of a non-atherosclerotic disorder.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311805

Locations

United States, Alabama
Cardiology, PC	Recruiting
Birmingham, Alabama, United States, 35211
Contact: Susan DeRamus, RN, CCRC 205-780-4330 ext 338 sderamus@cardiologypc.com
Principal Investigator: Farrell O Mendelsohn, MD
United States, Illinois
Northwestern University	Recruiting
Chicago, Illinois, United States, 60611
Contact: Sherrie Wolfe, RN 312-926-3413 s-wolfe@northwestern.edu
Contact: Rita Vargos, RN 312-695-0006 rvargos@northwestern.edu
Principal Investigator: Douglas W. Losordo, MD
United States, Minnesota
Minneapolis Heart Institute Foundation	Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Vicki Pink, RN, CCRC 612-863-6286 vpink@mplsheart.com
Contact: Jo Anne Goldman, RT, RCIS, CCRC 612-863-3793 joanne.goldman@allina.com
Principal Investigator: Timothy D Henry, MD

Sponsors and Collaborators

Losordo, Douglas, M.D.

Investigators

Principal Investigator:

Douglas W. Losordo, M.D.

Northwestern University

More Information

No publications provided

Responsible Party:	Northwestern University, Northwestern Memorial Hospital ( Director, Feinberg Cardiovascular Research Institute, Program in Cardiovascular Regenerative Medicine )
Study ID Numbers:	BB-IND 11931-001
Study First Received:	April 4, 2006
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00311805 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Arterial Occlusive Diseases
Signs and Symptoms
Vascular Diseases
Intermittent Claudication

Pain
Arteriosclerosis
Neovascularization, Pathologic

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Signs and Symptoms
Vascular Diseases

Intermittent Claudication
Cardiovascular Diseases
Arteriosclerosis

ClinicalTrials.gov processed this record on May 07, 2009