Study to Assess the Efficacy and Safety of CLBS12 in Patients With Critical Limb Ischemia (CLI)

• Register: ClinicalTrials.gov
• Last refreshed on: 7 November 2022
• Main ID: NCT02501018
• Date of registration: 14/07/2015
• Prospective Registration: Yes
• Primary sponsor: Lisata Therapeutics, Inc.
• Public title: Study to Assess the Efficacy and Safety of CLBS12 in Patients With Critical Limb Ischemia (CLI)
• Scientific title: A Prospective, Open Label, Controlled, Randomized, Multicenter Study to Assess the Efficacy and Safety of CLBS12 in Patients With Critical Limb Ischemia (CLI) Due to Arteriosclerosis Obliterans (ASO) With a Single-arm Substudy to Assess the Safety and Potential Efficacy of CLBS12 in Patients With CLI Due to Buerger's Disease (BD)
• Date of first enrolment: November 1, 2017
• Target sample size: 33
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02501018
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Japan

Contacts

• Name: Kristen K Buck, MD
• Affiliation: Lisata Therapeutics, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- subject has CLI caused by ASO or BD

Exclusion Criteria:

- < 20 years old



Age minimum: 20 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Critical Limb Ischemia

Buerger Disease

Thromboangiitis Obliterans

Atherosclerosis Obliterans

Intervention(s)

Drug: SOC

Biological: CLBS12

Primary Outcome(s)

Time to continuous CLI-free status [Time Frame: 1 year]

Secondary ID(s)

CLBS12-P01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors