Study to Assess the Efficacy and Safety of CLBS12 in Patients With Critical Limb Ischemia (CLI)
Primary Purpose
Critical Limb Ischemia, Buerger Disease, Thromboangiitis Obliterans
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
CLBS12
SOC
Sponsored by
About this trial
This is an interventional treatment trial for Critical Limb Ischemia focused on measuring CLI, ASO, TAO
Eligibility Criteria
Inclusion Criteria:
- subject has CLI caused by ASO or BD
Exclusion Criteria:
- < 20 years old
Sites / Locations
- Asahikawa Medical University Hospital - 1-1-1 Higashi-2jou
- Fukuoka Sanno Hospital
- Shonan Kamakura General Hospital
- Kobe City Medical Center General Hospital
- Shinsuma General Hospital
- Oita Oka Hospital
- Osaka Saiseikai Nakatsu Hospital
- Nippon Medical School Hospital
- Keio University Hospital
- Toho University Medical Center Ohashi Hospital
- Tokyo Medical University Hospital
- Tokyo Women's Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
CLI Due to ASO with CLBS12 + SOC
CLI Due to ASO with SOC
CLI Due to BD with CLBS12
Arm Description
This group of subjects with CLI due to ASO will be administered with CLBS12 + SOC for collecting efficacy and safety data.
This group of subjects with CLI due to ASO will be administered with SOC only.
CLBS12 will be administered to patients with CLI due to BD for collecting safety and efficacy data.
Outcomes
Primary Outcome Measures
Time to continuous CLI-free status
CLI-free is determined by assessing the Rutherford score (</=3) by the investigator and a central adjudication committee.
Secondary Outcome Measures
Full Information
NCT ID
NCT02501018
First Posted
July 14, 2015
Last Updated
October 26, 2022
Sponsor
Lisata Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02501018
Brief Title
Study to Assess the Efficacy and Safety of CLBS12 in Patients With Critical Limb Ischemia (CLI)
Official 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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
May 19, 2022 (Actual)
Study Completion Date
May 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lisata Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed Description
Main ASO Study: This study will compare safety and efficacy of intramuscular transplantation of autologous CD34+ cells (CLBS12) plus standard of care (SOC) pharmacotherapy (cell treatment arm) versus SOC pharmacotherapy alone (e.g., antiplatelets, anticoagulants, and vasodilators including prostanoids) (control arm) in subjects with CLI categorized as Rutherford score 4 or 5 due to ASO aged 20 to 85 years and with no endovascular or surgical revascularization options. Subjects assigned to the cell treatment arm will continue SOC pharmacotherapy and will also receive subcutaneous injections of GRAN® 5 ug/kg/day for 5 days and undergo apheresis on the last day of GRAN® administration. Then each subject in the cell treatment arm will receive intramuscular injections of autologous CD34+ cells. Subjects assigned to the control arm will continue to receive SOC pharmacotherapy alone with the possibility of receiving cell treatment via the rescue option.
BD Substudy: A single arm substudy is included to assess the safety and efficacy of intramuscular transplantation of CLBS12 in patients (N=~5) with CLI categorized as 4 or 5 Rutherford score due to BD aged 20 to 85 years. Subjects who give informed consent will be screened for eligibility within 28 days before registration. Subjects will continue SOC pharmacotherapy and will also receive subcutaneous injections of GRAN® 5 µg/kg/day for 5 days (Pretreatment Days 1 5) to mobilize CD34+ cells into the peripheral blood and undergo apheresis on pretreatment Day 5 to collect CD34+ cells. The choice of pharmacotherapy will be made by the investigators.
Each subject in a cell treatment arm will receive intramuscular injections of up to 1 × 10^6 autologous CD34+ cells/kg/limb. All subjects will be evaluated for efficacy and safety assessments during approximately 12 months.
Efficacy assessments include CLI free status, AFS, PFS, ABI, TBI, SPP, TcPO2, ICD, VAS, and AQA.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia, Buerger Disease, Thromboangiitis Obliterans, Atherosclerosis Obliterans
Keywords
CLI, ASO, TAO
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CLI Due to ASO with CLBS12 + SOC
Arm Type
Experimental
Arm Description
This group of subjects with CLI due to ASO will be administered with CLBS12 + SOC for collecting efficacy and safety data.
Arm Title
CLI Due to ASO with SOC
Arm Type
Active Comparator
Arm Description
This group of subjects with CLI due to ASO will be administered with SOC only.
Arm Title
CLI Due to BD with CLBS12
Arm Type
Experimental
Arm Description
CLBS12 will be administered to patients with CLI due to BD for collecting safety and efficacy data.
Intervention Type
Biological
Intervention Name(s)
CLBS12
Other Intervention Name(s)
CD34+ cells
Intervention Description
Intramuscular transfusion of CLBS12.
Intervention Type
Drug
Intervention Name(s)
SOC
Other Intervention Name(s)
Standard of care
Intervention Description
Standard of care (SOC) is defined as pharmacotherapy with approved drugs (e.g., antiplatelets, anticoagulants, and vasodilators including prostanoids).
Primary Outcome Measure Information:
Title
Time to continuous CLI-free status
Description
CLI-free is determined by assessing the Rutherford score (</=3) by the investigator and a central adjudication committee.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
subject has CLI caused by ASO or BD
Exclusion Criteria:
< 20 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen K Buck, MD
Organizational Affiliation
Lisata Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Asahikawa Medical University Hospital - 1-1-1 Higashi-2jou
City
Midorigaoka
State/Province
Asahikawa-shi
ZIP/Postal Code
078-8510
Country
Japan
Facility Name
Fukuoka Sanno Hospital
City
Fukuoka
Country
Japan
Facility Name
Shonan Kamakura General Hospital
City
Kamakura
Country
Japan
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
Country
Japan
Facility Name
Shinsuma General Hospital
City
Kobe
Country
Japan
Facility Name
Oita Oka Hospital
City
Oita
Country
Japan
Facility Name
Osaka Saiseikai Nakatsu Hospital
City
Osaka
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
Country
Japan
Facility Name
Toho University Medical Center Ohashi Hospital
City
Tokyo
Country
Japan
Facility Name
Tokyo Medical University Hospital
City
Tokyo
Country
Japan
Facility Name
Tokyo Women's Medical University
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
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Study to Assess the Efficacy and Safety of CLBS12 in Patients With Critical Limb Ischemia (CLI)
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