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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	26 September 2016
Main ID:	NCT01484574
Date of registration:	27/11/2011
Prospective Registration:	Yes
Primary sponsor:	Stempeutics Research Pvt Ltd
Public title:	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
Scientific title:	A Non-randomized, Open Label, Multicentric, Dose Ranging , Phase II Study Assessing the Efficacy and Safety of Intramuscular Administration of Stempeucel - CLI™ (ex Vivo Cultured Adult Bone Marrow Derived Allogeneic Mesenchymal Stem Cells) in Patients With Critical Limb Ischemia Due to Buerger's Disease
Date of first enrolment:	January 2012
Target sample size:	90
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT01484574
Study type:	Interventional
Study design:	Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase:	Phase 2

Countries of recruitment
India

Contacts

Name:	Dr Anirban Chatterjee
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Affiliation:	AMRI Hospital

Name:	Dr Sanjay Desai
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Affiliation:	M. S. Ramaiah Medical College

Name:	Dr Vidyasagaran T
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Affiliation:	Madras Medical College

Name:	Dr Rajiv Parakh
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Affiliation:	Medanta - The Medicity

Name:	Dr Santanu Dutta
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Affiliation:	Nightingale Hospital

Name:	Dr Anita Dhar
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Affiliation:	All India Institute of Medical Sciences, New Delhi

Name:	Dr Murali Krishna
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Affiliation:	Sri Jayadeva Institute of Cardiovascular Sciences & Research

Name:	Dr Alfred Augustine
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Affiliation:	KMC, Mangalore

Name:	Dr Radhakrishnan R
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Affiliation:	Sri Ramchandra Medical College

Name:	Dr Rajkumar M
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Affiliation:	Stanley Medical College

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Buerger's Disease

Critical Limb Ischemia

Intervention(s)

Biological: Allogeneic Mesenchymal Stem Cells

Primary Outcome(s)

Healing of ulcerations or reduction of ulcer area in the target limb [Time Frame: 24 months]

Relief of the rest pain [Time Frame: 24 months]

Relief of the rest pain [Time Frame: 6 months]

Healing of ulcerations or reduction of ulcer area in the target limb [Time Frame: 6 months]

Secondary Outcome(s)

The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s). [Time Frame: 6 and 24 months]

Pain free walking distance [Time Frame: 6 and 24 months]

Ankle brachial pressure index (ABPI) - measured by Doppler [Time Frame: 6 and 24 months]

Assessment of electrocardiogram (ECG) parameters [Time Frame: 6 and 24 months]

Angiogenesis - collateral blood vessels by Magnetic resonance angiogram (MRA) [Time Frame: 6 and 24 months]

Quality of life by King's College VascuQOL questionnaire [Time Frame: 6 and 24 months]

Assessment of clinical laboratory parameters [Time Frame: 6 and 24 months]

Increase in transcutaneous partial oxygen pressure (TcPO2) [Time Frame: 6 and 24 months]

Major amputation free survival [Time Frame: 6 and 24 months]

Physical examination findings and assessment of vital signs [Time Frame: 6 and 24 months]

Secondary ID(s)

SRPL/CLI/10-11/001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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