Clinical Trial: A Clinical Trial to Study the Efficacy and Safety of Stempeucel® in Patients With CLI Due to Buergers Disease
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
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
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 Summary: 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
Sponsor: Stempeutics Research Pvt Ltd
Current Primary Outcome:
- Relief of the rest pain [ Time Frame: 6 months ]
- Reduction of ulcer area in the target limb [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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: Same as current
Information By: Stempeutics Research Pvt Ltd
Dates:
Date Received: January 23, 2017
Date Started: February 20, 2017
Date Completion: October 2019
Last Updated: April 5, 2017
Last Verified: April 2017
