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A Clinical Trial to Study the Efficacy and Safety of Stempeucel® in Patients With CLI Due to Buergers Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056742
Recruitment Status : Withdrawn (Form 46 from DCGI for the manufacturing & commercial marketing of Stempeucel® directs Stempeutics to conduct PMS study. Hence this study is being terminated.)
First Posted : February 17, 2017
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Stempeutics Research Pvt Ltd

Tracking Information
First Submitted Date  ICMJE January 23, 2017
First Posted Date  ICMJE February 17, 2017
Last Update Posted Date April 7, 2017
Estimated Study Start Date  ICMJE February 20, 2017
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
  • Relief of the rest pain [ Time Frame: 6 months ]
  • Reduction of ulcer area in the target limb [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
  • Total walking distance [ Time Frame: 6 months and 24 months ]
  • Major amputation free survival [ Time Frame: 6 months and 24 months ]
  • Ankle brachial pressure index (ABPI) - measured by Doppler [ Time Frame: 6 months and 24 months ]
  • Quality of life (QOL) by King's College VascuQOL questionnaire [ Time Frame: 6 months and 24 months ]
  • Angiogenesis - collateral blood vessels by Magnetic resonance angiogram (MRA) [ Time Frame: 6 months and 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 14, 2017)
  • The type of adverse events AE(s), number of AE(s) and proportion of patients with AE(s). [ Time Frame: 6 months and 24 months ]
  • CVS mortality [ Time Frame: 6 months and 24 months ]
  • All-cause mortality [ Time Frame: 6 months and 24 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial to Study the Efficacy and Safety of Stempeucel® in Patients With CLI Due to Buergers Disease
Official Title  ICMJE A Single Arm, Open Label, Multicentric, Clinical Study Assessing the Efficacy and Safety of Stempeucel® (ex Vivo Cultured Adult Bone Marrow Derived Allogeneic Mesenchymal Stem Cells) in Patients With CLI Due to Buerger's Disease
Brief Summary This study is being conducted as an extension of the phase II clinical trial SRPL/CLI/10-11/001 (NCT01484574). The CDSCO has recommended flexibility for continued clinical study in consultation with ICMR, as per recommendation of Cellular biology based therapeutic drug evaluation committee (CBBTDEC).
Detailed Description This study will evaluate the safety and efficacy of intramuscular injection of stempeucel(R) (Ex vivo cultured adult bone marrow derived allogeneic mesenchymal stem cells) in Critical Limb Ischemia due to Buerger's Disease
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Critical Limb Ischemia Due to Buerger's Disease
Intervention  ICMJE Biological: Stempeucel(R)
Ex vivo cultured adult bone marrow derived allogeneic mesenchymal stem cells
Study Arms  ICMJE Experimental: Stem cells
Patients will receive intramuscular and local injection of stempeucel(R) in addition to standard protocol of care
Intervention: Biological: Stempeucel(R)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 5, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2017)
164
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Buerger's disease as diagnosed by Shionoya criteria
  2. Males or females (willing to use accepted methods of contraception during the course of the study) in the age group of 18-65 yrs.
  3. Established CLI in the study limb, clinically and hemodynamically confirmed as per Rutherford- III-5;
  4. 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) .
  5. Patients having infrapopliteal occlusive disease with rest pain and ischemic ulcer/necrosis (patients should have at least one measureable ulcer), who are not eligible for or have failed traditional revascularization treatment as per the investigators judgment (No option patients) .
  6. ABPI ≤ 0.6 or ankle pressure ≤ 50 mm Hg.
  7. 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:

  1. Patients with CLI indicated for major amputation during screening
  2. Atherosclerotic PAD
  3. Ulcers with exposure of tendon and/bone in the shin region.
  4. Previous above trans metatarsal amputation in study limb
  5. Any Lumbar sympathectomy procedure performed less than 90 days prior to the screening
  6. Patients with gait disturbance for reasons other than CLI
  7. Diagnosis of diabetes mellitus (type 1 or type 2)
  8. Patients having left ventricular ejection fraction < 35%
  9. Patients suffering from clinically relevant peripheral neuropathy
  10. History of stroke or myocardial infarction
  11. Patients who are contraindicated for MRA
  12. Patients with DVT in any limb.
  13. 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
  14. Documented terminal illness or cancer or any concomitant disease process with a life expectancy of <1 year
  15. Patients already enrolled in another investigational drug trial or completed within 3 months or those who have received stem cells in the past
  16. Patient with known hypersensitivity to the constituents of the stempeucel®- dimethyl sulfoxide (DMSO) or human serum albumin (HSA)
  17. History of severe alcohol or drug abuse within 3 months of screening
  18. Hb% < 10 gm% for males, Hb% < 9 gm% for females, serum creatinine ≥ 2mg%, serum Total Bilirubin ≥2mg%
  19. Pregnant and lactating women
  20. Patients tested positive for HIV 1 & 2, HCV, HBV, CMV, RPR antibodies and for HBsAg antigen
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03056742
Other Study ID Numbers  ICMJE SRPL/CLI/10-11/001 Version 4
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Stempeutics Research Pvt Ltd
Study Sponsor  ICMJE Stempeutics Research Pvt Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stempeutics Research Pvt Ltd
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP