Status:
COMPLETED
Mesenchymal Stem Cells in Critical Limb Ischemia
Lead Sponsor:
Stempeutics Research Pvt Ltd
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
This clinical trial aims to study the safety and efficacy of adult mesenchymal stem cells in critical limb ischemia.
Eligibility Criteria
Inclusion
- Males or females with non-child bearing potential in the age group of 18-60 yrs of Indian origin.
- 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
- Patients with CLI suitable for surgical or percutaneous revascularization as determined by the surgeon performing vascular procedure and patients with any acute/chronic inflammatory condition
- 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,
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00883870
Start Date
April 1 2009
End Date
August 1 2012
Last Update
March 5 2013
Active Locations (4)
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1
M.S.Ramaiah Memorial Hospital
Bangalore, Karnataka, India, 560054
2
Bhagawan Mahaveer Jain Heart Centre
Bangalore, Karnataka, India, 5660052
3
Amrita Institute of Medical Sciences
Kochi, Kerala, India, 682026
4
Sri Ganga Ram Hospital
New Delhi, New Delhi, India, 110060