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Physicians and Referring Clinicians

Do you have a patient that may benefit from a open-label Phase 2 Proof of Concept Study to Assess the Efficacy and Safety Of ASCT01 (Autologous Stem Cell Treatment) in Patients With Critical Limb Ischemia?

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Lifecells, LLC, is currently recruiting patients for a study to be conducted at Kansas City Vascular FOUNDATION

This study will assess the safety and efficacy of intra-arterial infusion and intramuscular injection of an autologous, bone marrow-derived stem cell preparation (ASCT01) n patients with critical limb ischemia who have exhausted all medical and surgical therapeutic options.

The safety and tolerability will be evaluated by regular monitoring of the general physical condition, vital signs, and the occurrence of AEs and SAEs, respectively.

Furthermore, the standard biochemical and blood variables (red and white blood cell counts, Hb, Ht, platelets, sodium, potassium, chloride, calcium, phosphor, ASAT, ALAT, bilirubin, total protein, albumin, AP, cholesterol (LDL,HDL), triglycerides, urea and creatinine, immunoglobulins, HBA1c, C-peptide) will be checked before the treatment as well as 30 and 90 days after the treatment.

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Status: Recruiting

Study design:
An open-label single arm phase 2 study to assess the efficacy and safety of ASCT01 (autologus stem cell transplanattion)  in patients with Critical Limb Ischemia, sponsored by Lifecells LLC.

Patients:
Patients must be age 18-80 yrs, with established CLI (Rutherford Category 4 or 5 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.

Purpose:
To assess the efficacy and safety of ASCT01 prepared from patients own bone marrow and delivered by catheter for intra-arterial administration and intra-muscular injections in patients with CLI.

Location:

Duration of the Study:
Screening period of approximately 7-14 days, study intervention requires about 24 hours of hospitalization for bone marrow extraction and administration of ASCT01 treatment. Study follow-up is for 12 months at specified intervals, with assessment of study endpoints at day 90.

More Information:
You may also view more complete information about this study (IND 15069) on www.ClinicalTrials.gov, a registry of clinical trials conducted in the United States and around the world.

For additional details and enrollment screening for the study please contact:

Kansas City Vascular Foundation (KCV).

Rebecca Thomas, CVRN - BC 816-842-5555 Ext. 1605 rthomas@kcvascular.com

Site Investigator: Karl R Stark, MD

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