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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01484574
Other study ID # SRPL/CLI/10-11/001
Secondary ID
Status Completed
Phase Phase 2
First received November 27, 2011
Last updated September 12, 2016
Start date January 2012
Est. completion date March 2016

Study information

Verified date September 2016
Source Stempeutics Research Pvt Ltd
Contact n/a
Is FDA regulated No
Health authority India: Drugs Controller General of India
Study type Interventional

Clinical Trial Summary

This is an open label, non-randomized, dose ranging study to evaluate the safety and efficacy of different doses of Stempeucel in critical limb ischemia patients.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date March 2016
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Buerger's disease as diagnosed by Shionoya 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:

- Patients with CLI indicated for major amputation during screening

- 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Biological:
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

Locations

Country Name City State
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 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 Division of Peripheral Vascular and Endovascular Sciences, Medanta - The Medicity Gurgaon Haryana
India Department of Vascular Surgery, AMRI Hospital Kolkata West Bengal
India Nightingale Hospital Kolkata West Bengal
India Department of Surgery, KMC, Mangalore Mangalore Karnataka
India Department of Surgical Disciplines, All India Institute of Medical Sciences New Delhi Delhi

Sponsors (1)

Lead Sponsor Collaborator
Stempeutics Research Pvt Ltd

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Relief of the rest pain Rest pain will be measured using rest pain scale (0 to10) 6 months No
Primary Healing of ulcerations or reduction of ulcer area in the target limb Complete ulcer healing defined as complete epithelisation of ulcer and partial ulcer healing as at least 30% decrease in ulcer size. 6 months No
Primary Relief of the rest pain Rest pain will be measured using rest pain scale (0 to 10) 24 months No
Primary Healing of ulcerations or reduction of ulcer area in the target limb Complete ulcer healing defined as complete epithelisation of ulcer and partial ulcer healing as at least 30% decrease in ulcer size. 24 months No
Secondary Pain free walking distance 6 and 24 months No
Secondary Major amputation free survival 6 and 24 months No
Secondary Ankle brachial pressure index (ABPI) - measured by Doppler 6 and 24 months No
Secondary Increase in transcutaneous partial oxygen pressure (TcPO2) 6 and 24 months No
Secondary Quality of life by King's College VascuQOL questionnaire 6 and 24 months No
Secondary Angiogenesis - collateral blood vessels by Magnetic resonance angiogram (MRA) 6 and 24 months No
Secondary The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s). 6 and 24 months Yes
Secondary Assessment of clinical laboratory parameters 6 and 24 months Yes
Secondary Physical examination findings and assessment of vital signs 6 and 24 months Yes
Secondary Assessment of electrocardiogram (ECG) parameters 6 and 24 months Yes
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