Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Stempeutics Research Pvt Ltd
ClinicalTrials.gov Identifier:
NCT01484574
First received: November 27, 2011
Last updated: September 12, 2016
Last verified: September 2016
  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
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 ]

Enrollment: 90
Study Start Date: January 2012
Study Completion Date: March 2016
Primary Completion Date: February 2014 (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
No Intervention: Control arm
Standard protocol of care alone

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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

Locations
India
Department of Surgical Disciplines, All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029
Division of Peripheral Vascular and Endovascular Sciences, Medanta - The Medicity
Gurgaon, Haryana, India, 122001
Department of Vascular and Endovascular Surgery, M. S. Ramaiah Medical College and Hospitals
Bangalore, Karnataka, India, 560066
Peripheral Vascular Surgery, Sri Jayadeva Institute of Cardiovascular Sciences & Research
Bangalore, Karnataka, India, 560069
Department of Surgery, KMC, Mangalore
Mangalore, Karnataka, India, 575001
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
Department of Vascular Surgery, Stanley Medical College
Chennai, Tamil Nadu, India, 91-44-24732266
Department of Vascular Surgery, AMRI Hospital
Kolkata, West Bengal, India, 700029
Nightingale Hospital
Kolkata, West Bengal, India, 700071
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

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: September 12, 2016
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
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Vasculitis

ClinicalTrials.gov processed this record on September 29, 2016