Status:
COMPLETED
Study to Assess Efficacy and Safety of Bone Marrow Derived Stem Cells in Patients With Critical Limb Ischemia
Lead Sponsor:
Lifecells, LLC.
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 lim...
Detailed Description
Efficacy will be determined by number of collateral arteries as assessed magnetic resonance angiography at baseline and again at 3 months, rate of major amputation (above the ankle) of the affected li...
Eligibility Criteria
Inclusion
- 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%
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01867190
Start Date
May 1 2013
End Date
March 1 2016
Last Update
February 22 2019
Active Locations (1)
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1
Kansas City Vascular Foundation (KCV)
North Kansas City, Missouri, United States, 64116