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
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2009-04-30
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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mesenchymal stem cells
Intramuscular injection
mesenchymal stem cells
Intramuscular injection
Placebo
Intramuscular injection
Plasmalyte A
Intramuscular injection
Interventions
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mesenchymal stem cells
Intramuscular injection
Plasmalyte A
Intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* Established CLI, clinically and hemodynamically confirmed as per Rutherford- II-4, III-5, or III-6; Patients having Infra-inguinal arterial occlusive disease with rest pain or ischemic ulcer/necrosis, who are not eligible for or have failed traditional revascularization treatment (No option patients)
* Ankle Brachial Pressure Index (ABPI) ≤ 0.6 or ankle pressure ≤ 70 mm Hg or TcPO2 ≤ 60 mmHg in the foot
* Patients if having associated Type II Diabetes, should be on medication and well controlled (HbA1c ≤ 8%) without complications
* 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
* Normal liver and renal function
* On regular medication for hypertension if any
Exclusion Criteria
* CLI patient requiring amputation proximal to trans-metatarsal level
* Patients with gait disturbance for reasons other than CLI.
* Type I diabetes
* Patients having respiratory complications/left ventricular ejection fraction \< 25%f) Stroke or myocardial infarction within last 3 months
* Patients who are contraindicated for MRA
* 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 less than 1 year
* Patients 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 ≥ 2mg%, Serum Total Bilirubin ≥2mg%, HbA1c \> 8%
* Women with child bearing potential, pregnant and lactating women.
* Patients tested positive for HIV 1, HCV, HBV,
18 Years
60 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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Suresh K R
Role: PRINCIPAL_INVESTIGATOR
Bhagawan Mahaveer Jain Heart Centre, Bangalore
Sanjay Desai
Role: PRINCIPAL_INVESTIGATOR
M.S.Ramaiah Memorial Hospital, Bangalore
Rajiv Parakh
Role: PRINCIPAL_INVESTIGATOR
Sri Ganga Ram Hospital, New Delhi
Sudhindran S
Role: PRINCIPAL_INVESTIGATOR
Amrita Institute of Medical Sciences, Kochi
Locations
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M.S.Ramaiah Memorial Hospital
Bangalore, Karnataka, India
Bhagawan Mahaveer Jain Heart Centre
Bangalore, Karnataka, India
Amrita Institute of Medical Sciences
Kochi, Kerala, India
Sri Ganga Ram Hospital
New Delhi, New Delhi, India
Countries
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References
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Gupta PK, Chullikana A, Parakh R, Desai S, Das A, Gottipamula S, Krishnamurthy S, Anthony N, Pherwani A, Majumdar AS. A double blind randomized placebo controlled phase I/II study assessing the safety and efficacy of allogeneic bone marrow derived mesenchymal stem cell in critical limb ischemia. J Transl Med. 2013 Jun 10;11:143. doi: 10.1186/1479-5876-11-143.
Other Identifiers
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SRPL/CLI/07-08/001
Identifier Type: -
Identifier Source: org_study_id
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