Health Condition 1: null- Critical Limb Ischemia
Conditions
Interventions
Intervention1: EX VIVO CULTURED ADULT ALLOGENIC MESENCHYMAL STEM CELLS: Single Intramuscular (IM) injection of Mesenchymal Stem Cells.
Dose: 2 million cells per Kg body weight at 40-60 multiple sites
Sponsors
Stempeutics Research Pvt Ltd
Manipal Acunova Ltd
Eligibility
Inclusion criteria
Inclusion criteria: a) Males or females with non-child bearing potential in the age group of 18-60 yrs of Indian origin.. b) 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) c) Ankle Brachial Pressure Index (ABPI) ≤ 0.6 or ankle pressure ≤ 70 mm Hg or TcPO2 ≤ 60 mmHg in the foot d) Patients if having associated Type II Diabetes, should be on medication and well controlled (HbA1c ≤ 8%) without complications e) 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 f) Normal liver and renal function g) On regular medication for hypertension if any
Exclusion criteria
Exclusion criteria: a) 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 b) CLI patient requiring amputation proximal to trans-metatarsal level c) Patients with gait disturbance for reasons other than CLI. d) Type I diabetes e) Patients having respiratory complications/left ventricular ejection fraction < 25% f) Stroke or myocardial infarction within last 3 months g) Patients who are contraindicated for MRA h) 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 i) Documented terminal illness or cancer or any concomitant disease process with a life expectancy of less than 1 year j) Patients already enrolled in another investigational drug trial or completed within 3 months. k) History of severe alcohol or drug abuse within 3 months of screening. l) Hb% < 10 gm%, Serum Creatinine &#8805; 2mg%, Serum Total Bilirubin &#8805;2mg%, HbA1c > 8% m) Women with child bearing potential, pregnant and lactating women. n) Patients tested positive for HIV 1, HCV, HBV, CMV, RPR o) Refusal or inability to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety end points are: The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s). Assessment of clinical laboratory parameters. Assessment of vital signs. Assessment of electrocardiogram (ECG) parameters.Timepoint: All primary safety and efficacy endpoints will assessed at 6th months comparing the baseline values. However safety will be monitored for the entire duration of study and at every visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy endpoints are: 1.Increase in transcutaneous partial oxygen pressure (TcPO2) 2.Ankle brachial pressure index (ABPI) measured by Doppler 3.Vasculogenesis by Magnetic resonance angiogram (MRA) 4.Prevention of Amputation of the target limb within study periodTimepoint: All the secondary endpoints are assessed mainly at 6th month and at the end of study | — |
Countries
India
Contacts
Public ContactDr Sudheer Balaraju
Manipal Acunova Ltd
Outcome results
None listed