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

September 12, 2016 updated by: Stempeutics Research Pvt Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110029
        • Department of Surgical Disciplines, All India Institute of Medical Sciences
    • Haryana
      • Gurgaon, Haryana, India, 122001
        • Division of Peripheral Vascular and Endovascular Sciences, Medanta - The Medicity
    • Karnataka
      • Bangalore, Karnataka, India, 560066
        • Department of Vascular and Endovascular Surgery, M. S. Ramaiah Medical College and Hospitals
      • Bangalore, Karnataka, India, 560069
        • Peripheral Vascular Surgery, Sri Jayadeva Institute of Cardiovascular Sciences & Research
      • Mangalore, Karnataka, India, 575001
        • Department of Surgery, KMC, Mangalore
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600003
        • Department of Vascular Surgery, Madras Medical College
      • Chennai, Tamil Nadu, India, 600116
        • Department of Vascular Surgery, Sri Ramchandra Medical College
      • Chennai, Tamil Nadu, India, 91-44-24732266
        • Department of Vascular Surgery, Stanley Medical College
    • West Bengal
      • Kolkata, West Bengal, India, 700029
        • Department of Vascular Surgery, AMRI Hospital
      • Kolkata, West Bengal, India, 700071
        • Nightingale Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Stempeucel - CLI
Biological: Allogeneic Mesenchymal Stem Cells
Single intramuscular administration of intermediate dose of stem cells
Other Names:
  • Stempeucel - CLI
EXPERIMENTAL: Intermediate dose
Stempeucel - CLI will be administered at intermediate dose
Biological: Allogeneic Mesenchymal Stem Cells
Single intramuscular administration of low dose of stem cells
Other Names:
  • Stempeucel - CLI
Biological: Allogeneic Mesenchymal Stem Cells
Single intramuscular administration of intermediate dose of stem cells
Other Names:
  • Stempeucel - CLI
NO_INTERVENTION: Control arm
Standard protocol of care alone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Relief of the rest pain
Time Frame: 6 months
Rest pain will be measured using rest pain scale (0 to10)
6 months
Healing of ulcerations or reduction of ulcer area in the target limb
Time Frame: 6 months
Complete ulcer healing defined as complete epithelisation of ulcer and partial ulcer healing as at least 30% decrease in ulcer size.
6 months
Relief of the rest pain
Time Frame: 24 months
Rest pain will be measured using rest pain scale (0 to 10)
24 months
Healing of ulcerations or reduction of ulcer area in the target limb
Time Frame: 24 months
Complete ulcer healing defined as complete epithelisation of ulcer and partial ulcer healing as at least 30% decrease in ulcer size.
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Pain free walking distance
Time Frame: 6 and 24 months
6 and 24 months
Major amputation free survival
Time Frame: 6 and 24 months
6 and 24 months
Ankle brachial pressure index (ABPI) - measured by Doppler
Time Frame: 6 and 24 months
6 and 24 months
Increase in transcutaneous partial oxygen pressure (TcPO2)
Time Frame: 6 and 24 months
6 and 24 months
Quality of life by King's College VascuQOL questionnaire
Time Frame: 6 and 24 months
6 and 24 months
Angiogenesis - collateral blood vessels by Magnetic resonance angiogram (MRA)
Time Frame: 6 and 24 months
6 and 24 months
The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s).
Time Frame: 6 and 24 months
6 and 24 months
Assessment of clinical laboratory parameters
Time Frame: 6 and 24 months
6 and 24 months
Physical examination findings and assessment of vital signs
Time Frame: 6 and 24 months
6 and 24 months
Assessment of electrocardiogram (ECG) parameters
Time Frame: 6 and 24 months
6 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stempeutics Research Pvt Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SRPL/CLI/10-11/001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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