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

This study is currently recruiting participants.
Verified February 2012 by Stempeutics Research Pvt Ltd
Sponsor:
Information provided by (Responsible Party):
Stempeutics Research Pvt Ltd
ClinicalTrials.gov Identifier:
NCT01484574
First received: November 27, 2011
Last updated: February 10, 2012
Last verified: February 2012

November 27, 2011
February 10, 2012
January 2012
September 2013   (final data collection date for primary outcome measure)
  • Relief of the rest pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Rest pain will be measured using rest pain scale (0 to10)
  • Healing of ulcerations or reduction of ulcer area in the target limb [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Complete ulcer healing defined as complete epithelisation of ulcer and partial ulcer healing as at least 30% decrease in ulcer size.
  • Relief of the rest pain [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Rest pain will be measured using rest pain scale (0 to 10)
  • Healing of ulcerations or reduction of ulcer area in the target limb [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Complete ulcer healing defined as complete epithelisation of ulcer and partial ulcer healing as at least 30% decrease in ulcer size.
Same as current
Complete list of historical versions of study NCT01484574 on ClinicalTrials.gov Archive Site
  • Pain free walking distance [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]
  • Major amputation free survival [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]
  • Ankle brachial pressure index (ABPI) - measured by Doppler [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]
  • Increase in transcutaneous partial oxygen pressure (TcPO2) [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]
  • Quality of life by King's College VascuQOL questionnaire [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]
  • Angiogenesis - collateral blood vessels by Magnetic resonance angiogram (MRA) [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]
  • The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s). [ Time Frame: 6 and 24 months ] [ Designated as safety issue: Yes ]
  • Assessment of clinical laboratory parameters [ Time Frame: 6 and 24 months ] [ Designated as safety issue: Yes ]
  • Physical examination findings and assessment of vital signs [ Time Frame: 6 and 24 months ] [ Designated as safety issue: Yes ]
  • Assessment of electrocardiogram (ECG) parameters [ Time Frame: 6 and 24 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Critical Limb Ischemia
  • Buerger's Disease
  • Biological: Allogeneic Mesenchymal Stem Cells
    Single intramuscular administration of low dose of stem cells
    Other Name: Stempeucel - CLI
  • Biological: Allogeneic Mesenchymal Stem Cells
    Single intramuscular administration of intermediate dose of stem cells
    Other Name: Stempeucel - CLI
  • Biological: Allogeneic Mesenchymal Stem Cells
    Single intramuscular administration of high dose of stem cells
    Other Name: Stempeucel - CLI
  • Other: Standard protocol of care
    Standard protocol of care alone
  • Experimental: Low dose
    Stempeucel - CLI will be administered at the lowest dose
    Intervention: Biological: Allogeneic Mesenchymal Stem Cells
  • Experimental: Intermediate dose
    Stempeucel - CLI will be administered at intermediate dose
    Intervention: Biological: Allogeneic Mesenchymal Stem Cells
  • Experimental: High dose
    Stempeucel - CLI will be administered at high dose
    Intervention: Biological: Allogeneic Mesenchymal Stem Cells
  • No Intervention: Control arm
    Standard protocol of care alone
    Intervention: Other: Standard protocol of care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
126
September 2015
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Pawan K Gupta, MD., DNB., PhD 91-80-25024605 pawan.kumarg@manipal.edu
Contact: Anoop CH, MD 91-80-25024605 anoop.ch@stempeutics.com
India
 
NCT01484574
SRPL/CLI/10-11/001
Yes
Stempeutics Research Pvt Ltd
Stempeutics Research Pvt Ltd
Not Provided
Principal Investigator: Dr Anirban Chatterjee AMRI Hospital
Principal Investigator: Dr Anita Dhar All India Institute of Medical Sciences, New Delhi
Principal Investigator: Dr Rajkumar M Stanley Medical College
Principal Investigator: Dr Radhakrishnan R Sri Ramchandra Medical College
Principal Investigator: Dr Vidyasagaran T Madras Medical College
Principal Investigator: Dr Alfred Augustine KMC, Mangalore
Principal Investigator: Dr Sanjay Desai M. S. Ramaiah Medical College
Principal Investigator: Dr Rajiv Parakh Medanta - The Medicity
Principal Investigator: Dr Santanu Dutta Nightingale Hospital
Principal Investigator: Dr Murali Krishna Sri Jayadeva Institute of Cardiovascular Sciences & Research
Stempeutics Research Pvt Ltd
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP