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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Recruitment Status : Withdrawn (Form 46 from DCGI for the manufacturing & commercial marketing of Stempeucel® directs Stempeutics to conduct PMS study.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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Due to Buerger's Disease Biological: Stempeucel(R) Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : February 20, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : October 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Stem cells
Patients will receive intramuscular and local injection of stempeucel(R) in addition to standard protocol of care
 Biological: Stempeucel(R)
Ex vivo cultured adult bone marrow derived allogeneic mesenchymal stem cells


Outcome Measures
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Primary Outcome Measures :
  1. Relief of the rest pain [ Time Frame: 6 months ]
  2. Reduction of ulcer area in the target limb [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Total walking distance [ Time Frame: 6 months and 24 months ]
  2. Major amputation free survival [ Time Frame: 6 months and 24 months ]
  3. Ankle brachial pressure index (ABPI) - measured by Doppler [ Time Frame: 6 months and 24 months ]
  4. Quality of life (QOL) by King's College VascuQOL questionnaire [ Time Frame: 6 months and 24 months ]
  5. Angiogenesis - collateral blood vessels by Magnetic resonance angiogram (MRA) [ Time Frame: 6 months and 24 months ]

Other Outcome Measures:
  1. 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 ]
  2. CVS mortality [ Time Frame: 6 months and 24 months ]
  3. All-cause mortality [ Time Frame: 6 months and 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056742


Locations
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India
Department of Surgical Disciplines, All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029
Department of Vascular and Endovascular Surgery, M. S. Ramaiah Medical College and Hospitals
Bangalore, Karnataka, India, 560066
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
Saveetha Medical College & Hospital
Chennai, Tamil Nadu, India, 602105
SRM Medical College Hospital and Research Centre
Chennai, Tamil Nadu, India, 603203
Health Point Hospital
Kolkata, West Bengal, India, 700025
Nightingale Hospital
Kolkata, West Bengal, India, 700071
Sponsors and Collaborators
Stempeutics Research Pvt Ltd
More Information
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Responsible Party: Stempeutics Research Pvt Ltd
ClinicalTrials.gov Identifier: NCT03056742     History of Changes
Other Study ID Numbers: SRPL/CLI/10-11/001 Version 4
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thromboangiitis Obliterans
Ischemia
Pathologic Processes
Arterial Occlusive Diseases
 Vascular Diseases
Cardiovascular Diseases
Vasculitis