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. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
Critical Limb Ischemia
Buerger's Disease
Biological: Allogeneic Mesenchymal Stem Cells
Other: Standard protocol of care
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Stempeutics Research Pvt Ltd:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 126
Study Start Date: January 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose
Stempeucel - CLI will be administered at the lowest dose
Biological: Allogeneic Mesenchymal Stem Cells
Single intramuscular administration of low dose of stem cells
Other Name: Stempeucel - CLI
Experimental: Intermediate dose
Stempeucel - CLI will be administered at intermediate dose
Biological: Allogeneic Mesenchymal Stem Cells
Single intramuscular administration of intermediate dose of stem cells
Other Name: Stempeucel - CLI
Experimental: High dose
Stempeucel - CLI will be administered at high dose
Biological: Allogeneic Mesenchymal Stem Cells
Single intramuscular administration of high dose of stem cells
Other Name: Stempeucel - CLI
No Intervention: Control arm
Standard protocol of care alone
Other: Standard protocol of care
Standard protocol of care alone

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01484574

Contacts
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

Locations
India
Department of Surgical Disciplines, All India Institute of Medical Sciences Not yet recruiting
New Delhi, Delhi, India, 110029
Contact: Dr Anita Dhar    91-11-26588500    dranitadharbhan@gmail.com   
Principal Investigator: Dr Anita Dhar         
Division of Peripheral Vascular and Endovascular Sciences, Medanta - The Medicity Not yet recruiting
Gurgaon, Haryana, India, 122001
Contact: Dr Rajiv Parakh    91-124-4141414    rparakh1@yahoo.co.in   
Principal Investigator: Dr Rajiv Parakh         
Department of Vascular and Endovascular Surgery, M. S. Ramaiah Medical College and Hospitals Recruiting
Bangalore, Karnataka, India, 560066
Contact: Dr Sanjay Desai    91-80-40528411    scdesai@hotmail.com   
Principal Investigator: Dr Sanjay Desai         
Peripheral Vascular Surgery, Sri Jayadeva Institute of Cardiovascular Sciences & Research Not yet recruiting
Bangalore, Karnataka, India, 560069
Contact: Dr Murali Krishna    91-80-22977400    drmurali1978@yahoo.co.in   
Principal Investigator: Dr Murali Krishna         
Department of Surgery, KMC, Mangalore Not yet recruiting
Mangalore, Karnataka, India, 575001
Contact: Dr Alfred Augustine    91-824-4255655    alfred.augustine@manipal.edu   
Principal Investigator: Dr Alfred Augustine         
Department of Vascular Surgery, Madras Medical College Recruiting
Chennai, Tamil Nadu, India, 600003
Contact: Dr. Vidyasagaran T    91-44-25305000    tvidyasagaran@gmail.com   
Principal Investigator: Dr. Vidyasagaran T         
Department of Vascular Surgery, Stanley Medical College Not yet recruiting
Chennai, Tamil Nadu, India, 91-44-24732266
Contact: Dr Rajkumar M    91-44-24732266    dr_rajkumar47@rediffmail.com   
Principal Investigator: Dr Rajkumar M         
Department of Vascular Surgery, Sri Ramchandra Medical College Recruiting
Chennai, Tamil Nadu, India, 600116
Contact: Dr Radhakrishnan R    91-44-45928500    rrkrishnan@hotmail.com   
Principal Investigator: Dr Radhakrishnan R         
Department of Vascular Surgery, AMRI Hospital Not yet recruiting
Kolkata, West Bengal, India, 700029
Contact: Dr Anirban Chatterjee    91-33-24612526    chatterjeeanirban@hotmail.com   
Principal Investigator: Dr Anirban Chatterjee         
Nightingale Hospital Recruiting
Kolkata, West Bengal, India, 700071
Contact: Dr Santanu Dutta    91-33-22826754    dr.santanudutta09@yahoo.co.in   
Principal Investigator: Dr Santanu Dutta         
Sponsors and Collaborators
Stempeutics Research Pvt Ltd
Investigators
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
  More Information

No publications provided

Responsible Party: Stempeutics Research Pvt Ltd
ClinicalTrials.gov Identifier: NCT01484574     History of Changes
Other Study ID Numbers: SRPL/CLI/10-11/001
Study First Received: November 27, 2011
Last Updated: February 10, 2012
Health Authority: India: Drugs Controller General of India

Keywords provided by Stempeutics Research Pvt Ltd:
Critical limb ischemia
Buerger's disease
Critical limb ischemia due to Buerger's disease

Additional relevant MeSH terms:
Ischemia
Thromboangiitis Obliterans
Arterial Occlusive Diseases
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Vasculitis

ClinicalTrials.gov processed this record on October 20, 2014