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Frequently Asked Questions (FAQs)

Frequently Asked Questions1. What is the purpose of the clinical study?

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.

2. What are the qualification to be a part of this study?

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.

3. How long will I be involved in this clinical study?

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.

4. How long will the procedure take?

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

5. Will all participants receive the stem cell treatments?

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.

6. Where is this clinical study being conducted?

This study is being conducted at Kansas City Vascular, P.C. by Dr. Karl Stark MD, FACS.

7. Are there any costs involved in this study?

All study procedures and expenses will be provided at no cost. 

8. Will I be paid to participate in the study?

No. THis is a clinical trial andis not a paid trial.  You may be reimbursed for travel expenses and some lodging for study visits.

9. What company is sponsoring this clinical study?

The company sponsoring this study is Lifecells, LLC.

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