This study seeks to determine if treatment with adult stem cells, taken from the patient’s own bone marrow, can improve healing and prevent amputation.
You must be between 18-80 years old with established CLI (Rutherford Category 4 to 5 or Fontaine Classification III-IV per the recommendations of the TASC) with angiographic evidence of significant infra-inguinal arterial occlusive disease with no surgical or interventional options for revascularization and no response to optimal medical care as confirmed by a vascular surgeon and/or physician.
Qualified subjects will spend 1 day in the hospital during the initial study period and will have an additional 5 outpatient visits over the following year. All study procedures will be provided at no cost.
Screening period of approximately 7-14 days. Study follow-up of 12 months at specified intervals, with assessment of study endpoints at day 90.
You will be given instructions concerning the time in the morning when you should come to the hospital. Study intervention requires 24 to 48 hours of hospitalization for bone marrow extraction and administration of the investigational treatment
This study is called a randomized double-blind placebo-controlled phase 2 proof of concept study. The decision as to which treatment you will undergo (investigational or control) is made at random (like flipping a coin). However, regardless of which treatment you receive, neither you nor the doctor administering the treatment will know which treatment you received.
This study is being conducted at Kansas City Vascular, P.C. by Dr. Karl Stark MD, FACS.
All study procedures and expenses will be provided at no cost.
No. THis is a clinical trial andis not a paid trial. You may be reimbursed for travel expenses and some lodging for study visits.
The company sponsoring this study is Lifecells, LLC.