Injection of Autologous CD34-Positive Cells for Critical Limb Ischemia

Status:	Completed
Conditions:	Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	21 - 80
Updated:	10/14/2017
Start Date:	December 2007
End Date:	August 2010

Injection of Autologous CD34-Positive Cells for Improved Symptomatic Relief and Ischemic Wound Healing in Subjects With Moderate or High-Risk Critical Limb Ischemia

The purpose of this study is to evaluate the safety and efficacy of intramuscular injections
of adult stem cells in patients with Critical Limb Ischemia (CLI).

Inclusion Criteria:

- 21-80 years of age

- moderate or high-risk Critical Limb Ischemia (Rutherford Clinical Severity Score 4 or
5)

- unsuitable for conventional revascularization

Exclusion Criteria:

- advanced CLI (Rutherford Clinical Severity Score 6) characterized by extensive tissue
loss or gangrene

- advance AV block or NYHA Class III or Class IV heart failure

- myocardial infarction within 3 months of treatment

- successful coronary or lower extremity revascularization within 3 months of study
enrollment

- arterial insufficiency in the lower extremity is the result of a non-atherosclerotic
disorder with the exception of thromboangitis obliterans (Buerger's Disease)

- co-morbidity associated with life expectancy of less than 1 year

We found this trial at

sites

Mount Sinai School of Medicine Division of Vascular Surgery

1470 Madison Avenue
New York, New York 10029

from

New York, NY