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

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

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Relief of the rest pain

Secondary Outcome

 Pain free walking distance

Condition

Critical Limb Ischemia

Intervention

Allogeneic Mesenchymal Stem Cells

Study Arms / Comparison Groups

 Low dose
Description:  Stempeucel - CLI will be administered at the lowest dose

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

90

Start Date

January 2012

Completion Date

March 2016

Primary Completion Date

February 2014

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
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Dr Anirban Chatterjee, , 

Location Countries

India

Location Countries

India

Administrative Informations


NCT ID

NCT01484574

Organization ID

SRPL/CLI/10-11/001


Responsible Party

Sponsor

Study Sponsor

Stempeutics Research Pvt Ltd


Study Sponsor

Dr Anirban Chatterjee, Principal Investigator, AMRI Hospital


Verification Date

September 2016