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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

Primary Purpose

Critical Limb Ischemia, Buerger's Disease

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Allogeneic Mesenchymal Stem Cells
Allogeneic Mesenchymal Stem Cells
Sponsored by
Stempeutics Research Pvt Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Limb Ischemia focused on measuring Critical limb ischemia, Buerger's disease, Critical limb ischemia due to Buerger's disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Surgical Disciplines, All India Institute of Medical Sciences
  • Division of Peripheral Vascular and Endovascular Sciences, Medanta - The Medicity
  • Department of Vascular and Endovascular Surgery, M. S. Ramaiah Medical College and Hospitals
  • Peripheral Vascular Surgery, Sri Jayadeva Institute of Cardiovascular Sciences & Research
  • Department of Surgery, KMC, Mangalore
  • Department of Vascular Surgery, Madras Medical College
  • Department of Vascular Surgery, Sri Ramchandra Medical College
  • Department of Vascular Surgery, Stanley Medical College
  • Department of Vascular Surgery, AMRI Hospital
  • Nightingale Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Low dose

Intermediate dose

Control arm

Arm Description

Stempeucel - CLI will be administered at the lowest dose

Stempeucel - CLI will be administered at intermediate dose

Standard protocol of care alone

Outcomes

Primary Outcome Measures

Relief of the rest pain
Rest pain will be measured using rest pain scale (0 to10)
Healing of ulcerations or reduction of ulcer area in the target limb
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
Rest pain will be measured using rest pain scale (0 to 10)
Healing of ulcerations or reduction of ulcer area in the target limb
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
Major amputation free survival
Ankle brachial pressure index (ABPI) - measured by Doppler
Increase in transcutaneous partial oxygen pressure (TcPO2)
Quality of life by King's College VascuQOL questionnaire
Angiogenesis - collateral blood vessels by Magnetic resonance angiogram (MRA)
The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s).
Assessment of clinical laboratory parameters
Physical examination findings and assessment of vital signs
Assessment of electrocardiogram (ECG) parameters

Full Information

First Posted
November 27, 2011
Last Updated
September 12, 2016
Sponsor
Stempeutics Research Pvt Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01484574
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stempeutics Research Pvt Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia, Buerger's Disease
Keywords
Critical limb ischemia, Buerger's disease, Critical limb ischemia due to Buerger's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose
Arm Type
Experimental
Arm Description
Stempeucel - CLI will be administered at the lowest dose
Arm Title
Intermediate dose
Arm Type
Experimental
Arm Description
Stempeucel - CLI will be administered at intermediate dose
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Standard protocol of care alone
Intervention Type
Biological
Intervention Name(s)
Allogeneic Mesenchymal Stem Cells
Other Intervention Name(s)
Stempeucel - CLI
Intervention Description
Single intramuscular administration of low dose of stem cells
Intervention Type
Biological
Intervention Name(s)
Allogeneic Mesenchymal Stem Cells
Other Intervention Name(s)
Stempeucel - CLI
Intervention Description
Single intramuscular administration of intermediate dose of stem cells
Primary Outcome Measure Information:
Title
Relief of the rest pain
Description
Rest pain will be measured using rest pain scale (0 to10)
Time Frame
6 months
Title
Healing of ulcerations or reduction of ulcer area in the target limb
Description
Complete ulcer healing defined as complete epithelisation of ulcer and partial ulcer healing as at least 30% decrease in ulcer size.
Time Frame
6 months
Title
Relief of the rest pain
Description
Rest pain will be measured using rest pain scale (0 to 10)
Time Frame
24 months
Title
Healing of ulcerations or reduction of ulcer area in the target limb
Description
Complete ulcer healing defined as complete epithelisation of ulcer and partial ulcer healing as at least 30% decrease in ulcer size.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Pain free walking distance
Time Frame
6 and 24 months
Title
Major amputation free survival
Time Frame
6 and 24 months
Title
Ankle brachial pressure index (ABPI) - measured by Doppler
Time Frame
6 and 24 months
Title
Increase in transcutaneous partial oxygen pressure (TcPO2)
Time Frame
6 and 24 months
Title
Quality of life by King's College VascuQOL questionnaire
Time Frame
6 and 24 months
Title
Angiogenesis - collateral blood vessels by Magnetic resonance angiogram (MRA)
Time Frame
6 and 24 months
Title
The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s).
Time Frame
6 and 24 months
Title
Assessment of clinical laboratory parameters
Time Frame
6 and 24 months
Title
Physical examination findings and assessment of vital signs
Time Frame
6 and 24 months
Title
Assessment of electrocardiogram (ECG) parameters
Time Frame
6 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Anirban Chatterjee
Organizational Affiliation
AMRI Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Anita Dhar
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Rajkumar M
Organizational Affiliation
Stanley Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Radhakrishnan R
Organizational Affiliation
Sri Ramchandra Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Vidyasagaran T
Organizational Affiliation
Madras Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Alfred Augustine
Organizational Affiliation
KMC, Mangalore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Sanjay Desai
Organizational Affiliation
M. S. Ramaiah Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Rajiv Parakh
Organizational Affiliation
Medanta - The Medicity
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Santanu Dutta
Organizational Affiliation
Nightingale Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr Murali Krishna
Organizational Affiliation
Sri Jayadeva Institute of Cardiovascular Sciences & Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgical Disciplines, All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Division of Peripheral Vascular and Endovascular Sciences, Medanta - The Medicity
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122001
Country
India
Facility Name
Department of Vascular and Endovascular Surgery, M. S. Ramaiah Medical College and Hospitals
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560066
Country
India
Facility Name
Peripheral Vascular Surgery, Sri Jayadeva Institute of Cardiovascular Sciences & Research
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560069
Country
India
Facility Name
Department of Surgery, KMC, Mangalore
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575001
Country
India
Facility Name
Department of Vascular Surgery, Madras Medical College
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600003
Country
India
Facility Name
Department of Vascular Surgery, Sri Ramchandra Medical College
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600116
Country
India
Facility Name
Department of Vascular Surgery, Stanley Medical College
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
91-44-24732266
Country
India
Facility Name
Department of Vascular Surgery, AMRI Hospital
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700029
Country
India
Facility Name
Nightingale Hospital
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700071
Country
India

12. IPD Sharing Statement

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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

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