A Clinical Trial to Study the Efficacy and Safety of Different Doses of Bone Marrow Derived Mesenchymal Stem Cells in Patients With Critical Limb Ischemia Due to Buergers Disease
NCT ID: NCT01484574
Last Updated: 2016-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2012-01-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low dose
Stempeucel - CLI will be administered at the lowest dose
Allogeneic Mesenchymal Stem Cells
Single intramuscular administration of low dose of stem cells
Intermediate dose
Stempeucel - CLI will be administered at intermediate dose
Allogeneic Mesenchymal Stem Cells
Single intramuscular administration of intermediate dose of stem cells
Control arm
Standard protocol of care alone
No interventions assigned to this group
Interventions
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Allogeneic Mesenchymal Stem Cells
Single intramuscular administration of low dose of stem cells
Allogeneic Mesenchymal Stem Cells
Single intramuscular administration of intermediate dose of stem cells
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 yrs
* Established CLI in the study limb, clinically and hemodynamically confirmed as per Rutherford- III-5
* Patients in Rutherford- III-6 if gangrene extending maximally up to the head of metatarsal but limited to toes (Patients with wet gangrene must undergo wound debridement / amputation before screening)
* Patients having infrapopliteal occlusive disease with rest pain and ischemic ulcer/necrosis, who are not eligible for or have failed traditional revascularization treatment as per the investigators judgment (No option patients)
* Ankle Brachial Pressure Index (ABPI) ≤ 0.6 or ankle pressure ≤ 50 mm Hg or TcPO2 ≤ 40 mmHg in the foot of the study limb
* Patients who are able to understand the requirements of the study, and willing to provide voluntary written informed consent and video consent, abide by the study requirements, and agree to return for required follow-up visits
Exclusion Criteria
* Atherosclerotic PAD
* Ulcers with exposure of tendon and/bone in the shin region
* Previous above transmetatarsal amputation in study limb
* Any Lumbar sympathectomy procedure performed less than 90 days prior to the screening
* Patients with gait disturbance for reasons other than CLI
* Diagnosis of diabetes mellitus (type 1 or type 2)
* Patients having left ventricular ejection fraction \< 35%
* Patients suffering from clinically relevant peripheral neuropathy
* History of Stroke or myocardial infarction
* Patients who are contraindicated for MRA
* Patients with deep vein thrombosis in any limb
* Patients who have clinically serious and/or unstable inter-current infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the 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 \<1 year
* Patients already enrolled in another investigational drug trial or completed within 3 months or those who have participated in any stem cell clinical trial
* Patient with known hypersensitivity to the constituents of the IMP - dimethyl sulfoxide (DMSO) or human serum albumin (HSA)
* History of severe alcohol or drug abuse within 3 months of screening
* Hb% \< 10 gm% for males, Hb% \< 9 gm% for females, serum creatinine ≥ 2mg%, serum Total Bilirubin ≥2mg%
* Pregnant and lactating women
* Patients tested positive for HIV 1, HCV, HBV, CMV, RPR
18 Years
65 Years
ALL
No
Sponsors
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Stempeutics Research Pvt Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Dr Anirban Chatterjee
Role: PRINCIPAL_INVESTIGATOR
AMRI Hospital
Dr Anita Dhar
Role: PRINCIPAL_INVESTIGATOR
All India Institute of Medical Sciences
Dr Rajkumar M
Role: PRINCIPAL_INVESTIGATOR
Stanley Medical College
Dr Radhakrishnan R
Role: PRINCIPAL_INVESTIGATOR
Sri Ramchandra Medical College
Dr Vidyasagaran T
Role: PRINCIPAL_INVESTIGATOR
Madras Medical College
Dr Alfred Augustine
Role: PRINCIPAL_INVESTIGATOR
KMC, Mangalore
Dr Sanjay Desai
Role: PRINCIPAL_INVESTIGATOR
M. S. Ramaiah Medical College
Dr Rajiv Parakh
Role: PRINCIPAL_INVESTIGATOR
Medanta - The Medicity
Dr Santanu Dutta
Role: PRINCIPAL_INVESTIGATOR
Nightingale Hospital
Dr Murali Krishna
Role: PRINCIPAL_INVESTIGATOR
Sri Jayadeva Institute of Cardiovascular Sciences & Research
Locations
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Division of Peripheral Vascular and Endovascular Sciences, Medanta - The Medicity
Gurgaon, Haryana, India
Department of Vascular and Endovascular Surgery, M. S. Ramaiah Medical College and Hospitals
Bangalore, Karnataka, India
Peripheral Vascular Surgery, Sri Jayadeva Institute of Cardiovascular Sciences & Research
Bangalore, Karnataka, India
Department of Surgery, KMC, Mangalore
Mangalore, Karnataka, India
Department of Surgical Disciplines, All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Department of Vascular Surgery, Madras Medical College
Chennai, Tamil Nadu, India
Department of Vascular Surgery, Sri Ramchandra Medical College
Chennai, Tamil Nadu, India
Department of Vascular Surgery, Stanley Medical College
Chennai, Tamil Nadu, India
Department of Vascular Surgery, AMRI Hospital
Kolkata, West Bengal, India
Nightingale Hospital
Kolkata, West Bengal, India
Countries
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Other Identifiers
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SRPL/CLI/10-11/001
Identifier Type: -
Identifier Source: org_study_id
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