NCT02477540

A Safety and Efficacy Study of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Critical Limb Ischemia

An Open Labeled, Single-center, Phase I Study Assessing the Safety and Efficacy of Autologous Bone Marrow Derived Mesenchymal Stem Cells in Critical Limb Ischemia

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pharmicell Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial to study the Safety and Efficacy of Autologous Mesenchymal stem cells in critical limb ischemia.

Detailed description

If the participant voluntarily agrees to participate in the clinical trial before registration, the investigator conducts a screening test to evaluate the participant's suitability. A participant that satisfies all inclusion and exclusion criteria is assigned a test group(2-time injection group). Participants conduct cell therapy within 30 days after bone marrow aspiration, and will re-inject autologous mesenchymal stem cells within 30 days after first injection. Participants will make a total of 5 hospital visits after registration, and Safety and Efficacy will be evaluated based on a fixed procedure on every visit.

Conditions

• Critical Limb Ischemia

Interventions

Type	Name	Description
DRUG	Cellgram-CLI	Appearance: White cell suspension is filled in a clear plastic syringe, and fixed with an occlude on the prefilled syringe tip Main ingredient: Autologous bone marrow-derived mesenchymal stem cells Dosage: 50,000,000 cells/10ml, 2-time injection Storage: An airtight container, 20\~25℃ Injection Method: Intramuscular

Timeline

• Start date: 2019-12-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2015-06-22
• Last updated: 2019-03-22