Study to Assess Efficacy and Safety of Bone Marrow Derived Stem Cells in Patients With Critical Limb Ischemia

Completed · Phase 2

Conditions studied: Critical Limb Ischemia

In brief

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) in 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 AE and SAE, 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.

Key facts

Study ID

NCT01867190

Run by

Lifecells, LLC.

People needed

24

Starts

2013-05-01

Expected to finish

2016-03-01

Last updated by the study team

2019-02-22

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and Female patients in the age group of 18-80yrs.
• Established CLI (confirmed by Rutherford 4 to 5) with angiographic evidence of significant infra-inguinal arterial occlusive disease
• Ankle Brachial Pressure Index (ABI) ≤ 0.6 or the absolute ankle blood pressure < 60 mm Hg or TcPO2<20 mmHg without tissue loss or TcPO2<40 mmHg if there is tissue loss or alternatively toe Brachial Pressure Index (TBI) less 0.5 or the absolute toe blood pressure less than 50 mm Hg
• No surgical or interventional option for revascularization and no response to best standard care delivered as confirmed by a vascular surgeon and/or physician.
• No immediate life-threatening complication from CLI which would demand immediate amputation.
• Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent, abide by the study requirements, and agree to return for required follow-up visits.
• On optimal medical therapy
• If diabetic, HgbA1c <10%

You may not qualify if…

• Acute life threatening complication of limb ischemia with the need for immediate limb amputation to avoid death or clinical deterioration
• Patients with confirmed Rutherford 6 condition with extensive tissue damage
• Patients with documented terminal illness or cancer or any concomitant disease process with a life expectancy of less than 6 months.
• Patients with a history of severe alcohol or drug abuse within 3 months of screening.
• Known bone marrow diseases which preclude transplantation.
• End-stage renal failure on regular dialysis treatment. Creatinine ≥2.0 mg/dl
• Patients already enrolled in another investigational drug trial or completed within 1month.
• Pregnancy.
• Patients tested positive for HIV screen1or2, Hepatitis C antibody Hepatitis B surface-antigen, HepatitisBcore Antibody, Syphilis screen
• Myocardial infarction / CVA / TIA within the past three months prior to enrollment
• Revascularization procedure in target limb within 6 weeks prior to enrollment
• Laboratory values as show below*
• Currently taking immunosuppressive agents
• If diabetic, diagnosis of proliferative retinopathy
• Patients with infected ulcers or systemic infections *Laboratory Values: Hemoglobin <10 g/dL Platelet count <100,000/microL ALT >60 U/L AST >60 U/L Bilirubin >1.0 mg/dL INR >1.3 unless on Coumadin and at Investigator discretion APTT >40 second unless on Lovenox or Heparin and at Investigator's discretion

Where it is running

• Kansas City Vascular Foundation (KCV) — North Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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