A Clinical Trial to Study the Efficacy and Safety of Stempeucel® in Patients With CLI Due to Buergers Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03056742 |
Recruitment Status :
Withdrawn
(Form 46 from DCGI for the manufacturing & commercial marketing of Stempeucel® directs Stempeutics to conduct PMS study. Hence this study is being terminated.)
First Posted : February 17, 2017
Last Update Posted : April 7, 2017
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Condition or disease | Intervention/treatment | Phase |
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Critical Limb Ischemia Due to Buerger's Disease | Biological: Stempeucel(R) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Single Arm, Open Label, Multicentric, Clinical Study Assessing the Efficacy and Safety of Stempeucel® (ex Vivo Cultured Adult Bone Marrow Derived Allogeneic Mesenchymal Stem Cells) in Patients With CLI Due to Buerger's Disease |
Estimated Study Start Date : | February 20, 2017 |
Estimated Primary Completion Date : | April 2018 |
Estimated Study Completion Date : | October 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Stem cells
Patients will receive intramuscular and local injection of stempeucel(R) in addition to standard protocol of care
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Biological: Stempeucel(R)
Ex vivo cultured adult bone marrow derived allogeneic mesenchymal stem cells |
- Relief of the rest pain [ Time Frame: 6 months ]
- Reduction of ulcer area in the target limb [ Time Frame: 6 months ]
- Total walking distance [ Time Frame: 6 months and 24 months ]
- Major amputation free survival [ Time Frame: 6 months and 24 months ]
- Ankle brachial pressure index (ABPI) - measured by Doppler [ Time Frame: 6 months and 24 months ]
- Quality of life (QOL) by King's College VascuQOL questionnaire [ Time Frame: 6 months and 24 months ]
- Angiogenesis - collateral blood vessels by Magnetic resonance angiogram (MRA) [ Time Frame: 6 months and 24 months ]
- The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s). [ Time Frame: 6 months and 24 months ]
- CVS mortality [ Time Frame: 6 months and 24 months ]
- All-cause mortality [ Time Frame: 6 months and 24 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 (patients should have at least one measureable ulcer), who are not eligible for or have failed traditional revascularization treatment as per the investigators judgment (No option patients) .
- ABPI ≤ 0.6 or ankle pressure ≤ 50 mm Hg.
- 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 trans metatarsal 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 DVT 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 received stem cells in the past
- Patient with known hypersensitivity to the constituents of the stempeucel®- 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 & 2, HCV, HBV, CMV, RPR antibodies and for HBsAg antigen

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056742
India | |
Department of Surgical Disciplines, All India Institute of Medical Sciences | |
New Delhi, Delhi, India, 110029 | |
Department of Vascular and Endovascular Surgery, M. S. Ramaiah Medical College and Hospitals | |
Bangalore, Karnataka, India, 560066 | |
Department of Vascular Surgery, Madras Medical College | |
Chennai, Tamil Nadu, India, 600003 | |
Department of Vascular Surgery, Sri Ramchandra Medical College | |
Chennai, Tamil Nadu, India, 600116 | |
Saveetha Medical College & Hospital | |
Chennai, Tamil Nadu, India, 602105 | |
SRM Medical College Hospital and Research Centre | |
Chennai, Tamil Nadu, India, 603203 | |
Health Point Hospital | |
Kolkata, West Bengal, India, 700025 | |
Nightingale Hospital | |
Kolkata, West Bengal, India, 700071 |
Responsible Party: | Stempeutics Research Pvt Ltd |
ClinicalTrials.gov Identifier: | NCT03056742 |
Other Study ID Numbers: |
SRPL/CLI/10-11/001 Version 4 |
First Posted: | February 17, 2017 Key Record Dates |
Last Update Posted: | April 7, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Thromboangiitis Obliterans Ischemia Pathologic Processes Arterial Occlusive Diseases |
Vascular Diseases Cardiovascular Diseases Vasculitis |