Status:
COMPLETED
Safety and Efficacy of Autologous Bone Marrow Mononuclear Cells in Patients With Severe Critical Limb Ischemia
Lead Sponsor:
TotipotentSC Scientific Product Pvt. Ltd.
Collaborating Sponsors:
Thermogenesis Corp.
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the concentrated autologous bone marrow derived stem cells for the treatment of Critical Limb Ischemia patients.
Detailed Description
A total of 15 patients suffering from end stage IV and V Rutherford /CLI in whom all previous therapeutic strategies failed (e.g. surgical revascularization) will be selected and undergo local transpl...
Eligibility Criteria
Inclusion
- Atherosclerotic ischemic peripheral vascular disease (PVD) or Thromboangiitis Obliterans with severe Critical Limb Ischemia (Rutherford Category 4 and 5: ischemic pain at rest and minor tissue loss and Fontaine Class 4: Ischemic ulcers or gangrene, whivh may be dry or humid).
- A non-surgical candidate for revascularization e.g. prior vascular reconstruction, inability to locate a suitable vein for grafting, diffuse multi- segment disease, or extensive infra-popliteal disease not amenable to a vascular graft.
- Major amputation recommended patients due to severe life threatening PAD.
- Subjects must be on maximal tolerated medical therapy for peripheral vascular disease including A) Cessation of smoking B) Referral to endocrinologist for control of HgA1c to \< 8% mg/dl, C) control of hyperlipidemia with statins or other anti-hyperlipidemic drugs as indicated, D) control of hypertension as indicated E) Antiplatelet therapy with aspirin and / or cilostazol (unless medically contraindicated, e.g. bleeding or allergy).
- Ankle Brachial Pressure Index (ABI) ≤ 0.6 or ankle systolic pressure ≤ 60 mm Hg or TcPO2 ≤ 35 mmHg in the foot.
- Subjects who are able to understand the requirements of the study, and willing to provide voluntary written informed consent, which abide by the study requirements, and agree to return for required follow-up visits.
Exclusion
- Subjects with CLI suitable for surgical or percutaneous revascularization and Subjects with acute and chronic inflammatory condition.
- CLI patient requiring amputation proximal to trans-metatarsal level
- Subjects with spreading (wet) gangrene
- Subjects with gait disturbance for reasons other than CLI.
- Subjects with poorly controlled diabetes mellitus.
- Subjects diagnosed with Thromboangiitis Obliterans (Buerger's Disease) who are smokers and are unwilling or unable to quit smoking or the physician feels the smoking cessation is doubtful.
- Subjects having moderate to severe COPD with GOLD Classification IIb or III.
- Uncontrolled congestive heart failure or Subjects with left ventricular ejection fraction \< 25% or AHA Stage C or D heart failure or NYHA Class IV CHF
- Stroke or myocardial infarction within last 3 months.
- Subjects who are contraindicated for CT Angiogram.
- Illnesses or conditions that are uncontrolled or whose control, in the opinion of the Principal Investigator, may be jeopardized by participation in this study or by the complications of this therapy.
- Documented terminal illness or cancer or any concomitant disease process with a life expectancy of less than 1 year.
- Subjects already enrolled in another investigational drug trial or completed within 3 months.
- History of severe alcohol or drug abuse within 3 months of screening.
- Hb% \< 10 gm%; Serum creatinine ≥ 2.0mg%; Serum total bilirubin ≥2.0mg%; HbA1c \> 8.0%.
- Women of child bearing potential; pregnant and lactating women.
- Subjects with a) myocardial infarction within the last 30 days or left ventricular ejection fraction \< 35%, B) Subjects with a cerebrovascular accident within the last 6 months.
- INR \> 1.5 at the time of Bone Marrow harvest.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01472289
Start Date
February 1 2011
End Date
July 1 2013
Last Update
November 18 2015
Active Locations (1)
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1
Fortis Escorts Heart Institute & Research Centre
New Delhi, New Delhi, India