NCT03056742

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Stempeutics Research Pvt Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Critical Limb Ischemia Due to Buerger's Disease

Interventions

Type	Name	Description
BIOLOGICAL	Stempeucel(R)	Ex vivo cultured adult bone marrow derived allogeneic mesenchymal stem cells

Timeline

• Start date: 2017-02-20
• Primary completion: 2018-04-01
• Completion: 2019-10-01
• First posted: 2017-02-17
• Last updated: 2017-04-07

Locations

8 sites across 1 country: India