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

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ClinicalTrials.gov Identifier: NCT02501018
Recruitment Status : Recruiting
First Posted : July 17, 2015
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Caladrius Biosciences, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Buerger Disease Thromboangiitis Obliterans Atherosclerosis Obliterans Biological: CLBS12 Drug: SOC Phase 2

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 80 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 80 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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CLI Due to ASO with CLBS12 + SOC
This group of subjects with CLI due to ASO will be administered with CLBS12 + SOC for collecting efficacy and safety data.
 Biological: CLBS12
Intramuscular transfusion of CLBS12.
Other Name: CD34+ cells

Drug: SOC
Standard of care (SOC) is defined as pharmacotherapy with approved drugs (e.g., antiplatelets, anticoagulants, and vasodilators including prostanoids).
Other Name: Standard of care
Active Comparator: CLI Due to ASO with SOC
This group of subjects with CLI due to ASO will be administered with SOC only.
 Drug: SOC
Standard of care (SOC) is defined as pharmacotherapy with approved drugs (e.g., antiplatelets, anticoagulants, and vasodilators including prostanoids).
Other Name: Standard of care
Experimental: CLI Due to BD with CLBS12
CLBS12 will be administered to patients with CLI due to BD for collecting safety and efficacy data.
 Biological: CLBS12
Intramuscular transfusion of CLBS12.
Other Name: CD34+ cells

Drug: SOC
Standard of care (SOC) is defined as pharmacotherapy with approved drugs (e.g., antiplatelets, anticoagulants, and vasodilators including prostanoids).
Other Name: Standard of care


Outcome Measures
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Primary Outcome Measures :
  1. Time to continuous CLI-free status [ Time Frame: 1 year ]
    CLI-free is determined by assessing the Rutherford score (</=3) by the investigator and a central adjudication committee.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subject has CLI caused by ASO or BD

Exclusion Criteria:

  • < 20 years old
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501018


Contacts
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Contact: Hiroshi Takagi +1 908 842 0080 htakagi@caladrius.com

Locations
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Japan
Asahikawa Medical University Hospital - 1-1-1 Higashi-2jou Recruiting
Midorigaoka, Asahikawa-shi, Japan, 078-8510
Contact: Yoshiyuki Takahashi    +81 78 304 7316    takahashi@fbri.org   
Fukuoka Sanno Hospital Recruiting
Fukuoka, Japan
Contact: Yoshiyuki Takahashi    +81 78 304 7316    takahashi@fbri.org   
Shonan Kamakura General Hospital Recruiting
Kamakura, Japan
Contact: Yoshiyuki Takahashi    +81 78 304 7316    takahashi@fbri.org   
Kobe City Medical Center General Hospital Recruiting
Kobe, Japan
Contact: Yoshiyuki Takahashi    +81 78 304 7316    takahashi@fbri.org   
Shinsuma General Hospital Not yet recruiting
Kobe, Japan
Contact: Yoshiyuki Takahashi    +81 78 304 7316    takahashi@fbri.org   
Oita Oka Hospital Recruiting
Oita, Japan
Contact: Yoshiyuki Takahashi    +81 78 304 7316    takahashi@fbri.org   
Osaka Saiseikai Nakatsu Hospital Recruiting
Osaka, Japan
Contact: Yoshiyuki Takahashi    +81 78 304 7316    takahashi@fbri.org   
Nippon Medical School Hospital Recruiting
Tokyo, Japan, 113-8603
Contact: Yoshiyuki Takahashi    +81 78 304 7316    takahashi@fbri.org   
Keio University Hospital Recruiting
Tokyo, Japan
Contact: Yoshiyuki Takahashi    +81 78 304 7316    takahashi@fbri.org   
Contact: T         
Toho University Medical Center Ohashi Hospital Recruiting
Tokyo, Japan
Contact: Yoshiyuki Takahashi    +81 78 304 7316    takahashi@fbri.org   
Tokyo Medical University Hospital Recruiting
Tokyo, Japan
Contact: Yoshiyuki Takahashi    +81 78 304 7316    takahashi@fbri.org   
Tokyo Women's Medical University Recruiting
Tokyo, Japan
Contact: Yoshiyuki Takahashi    +81 78 304 7316    takahashi@fbri.org   
Sponsors and Collaborators
Caladrius Biosciences, Inc.
More Information
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Additional Information:
Sponsor website  This link exits the ClinicalTrials.gov site

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Responsible Party: Caladrius Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02501018     History of Changes
Other Study ID Numbers: CLBS12-P01
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Caladrius Biosciences, Inc.:
CLI, ASO, TAO
Additional relevant MeSH terms:
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Atherosclerosis
Thromboangiitis Obliterans
Ischemia
Pathologic Processes
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Vasculitis