Study to Assess the Efficacy and Safety of CLBS12 in Patients with Critical Limb Ischemia (CLI)
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)
1 other identifier
interventional
33
1 country
12
Brief Summary
A prospective, open label, controlled, randomized, double arm, multi-center 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 sub-study to assess the safety and potential efficacy of CLBS12 in patients with CLI due to Buerger's Disease (BD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2017
Typical duration for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2015
CompletedFirst Posted
Study publicly available on registry
July 17, 2015
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 19, 2022
CompletedOctober 9, 2024
October 1, 2024
4.5 years
July 14, 2015
October 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to continuous CLI-free status
CLI-free is determined by assessing the Rutherford score (\</=3) by the investigator and a central adjudication committee.
1 year
Study Arms (3)
CLI Due to ASO with CLBS12 + SOC
EXPERIMENTALThis group of subjects with CLI due to ASO will be administered with CLBS12 + SOC for collecting efficacy and safety data.
CLI Due to ASO with SOC
ACTIVE COMPARATORThis group of subjects with CLI due to ASO will be administered with SOC only.
CLI Due to BD with CLBS12
EXPERIMENTALCLBS12 will be administered to patients with CLI due to BD for collecting safety and efficacy data.
Interventions
Intramuscular transfusion of CLBS12.
Standard of care (SOC) is defined as pharmacotherapy with approved drugs (e.g., antiplatelets, anticoagulants, and vasodilators including prostanoids).
Eligibility Criteria
You may qualify if:
- subject has CLI caused by ASO or BD
You may not qualify if:
- \< 20 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Asahikawa Medical University Hospital - 1-1-1 Higashi-2jou
Midorigaoka, Asahikawa-shi, 078-8510, Japan
Fukuoka Sanno Hospital
Fukuoka, Japan
Shonan Kamakura General Hospital
Kamakura, Japan
Kobe City Medical Center General Hospital
Kobe, Japan
Shinsuma General Hospital
Kobe, Japan
Osaka Saiseikai Nakatsu Hospital
Osaka, Japan
Oita Oka Hospital
Ōita, Japan
Nippon Medical School Hospital
Tokyo, 113-8603, Japan
Keio University Hospital
Tokyo, Japan
Toho University Medical Center Ohashi Hospital
Tokyo, Japan
Tokyo Medical University Hospital
Tokyo, Japan
Tokyo Women's Medical University
Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kristen K Buck, MD
Lisata Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2015
First Posted
July 17, 2015
Study Start
November 1, 2017
Primary Completion
May 19, 2022
Study Completion
May 19, 2022
Last Updated
October 9, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share