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

• ClinicalTrials.gov Identifier: NCT03056742
• Recruitment Status: Withdrawn
• First Posted: February 17, 2017
• Last Update Posted: April 7, 2017
• Sponsor: Stempeutics Research Pvt Ltd
• Information provided by (Responsible Party): Stempeutics Research Pvt Ltd

Tracking Information

• First Submitted Date: January 23, 2017
• First Posted Date: February 17, 2017
• Last Update Posted Date: April 7, 2017
• Estimated Study Start Date: February 20, 2017
• Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: 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: A Clinical Trial to Study the Efficacy and Safety of Stempeucel® in Patients With CLI Due to Buergers Disease
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Critical Limb Ischemia Due to Buerger's Disease

Intervention

Biological: Stempeucel(R)

Ex vivo cultured adult bone marrow derived allogeneic mesenchymal stem cells

Study Arms

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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: April 5, 2017): 0
• Original Estimated Enrollment (submitted: February 14, 2017): 164
• Estimated Study Completion Date: October 2019
• Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT03056742
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Stempeutics Research Pvt Ltd
• Study Sponsor: Stempeutics Research Pvt Ltd
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Stempeutics Research Pvt Ltd
• Verification Date: April 2017