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Trial record 1 of 2 for:    clbs16
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Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03508609
Recruitment Status : Completed
First Posted : April 26, 2018
Results First Posted : January 8, 2021
Last Update Posted : January 8, 2021
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Cedars-Sinai Medical Center
Mayo Clinic
Information provided by (Responsible Party):
Lisata Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE April 16, 2018
First Posted Date  ICMJE April 26, 2018
Results First Submitted Date  ICMJE November 17, 2020
Results First Posted Date  ICMJE January 8, 2021
Last Update Posted Date January 8, 2021
Actual Study Start Date  ICMJE April 19, 2018
Actual Primary Completion Date December 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2020)
Change From Baseline in Coronary Flow Reserve [ Time Frame: Day 180 ]
Coronary Flow Reserve (CFR) is a measure of coronary microvascular function.
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2018)
Change from baseline in coronary flow reserve [ Time Frame: Day 180 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2020)
  • Change From Baseline in Microvascular Function as Assessed by Intracoronary Administration of Acetylcholine [ Time Frame: Day 180 ]
  • Change From Baseline in Peripheral Arterial Tonometry [ Time Frame: Day 180 ]
  • Change in Angina Frequency From Baseline [ Time Frame: 6 months ]
  • Canadian Cardiovascular Society Angina Class [ Time Frame: 6 months ]
    Canadian Cardiovascular Society angina class grading scale is assessed according to the following scores: Grade 1: Ordinary physical activity does not cause angina, such as walking and climbing stairs. Angina with strenuous or rapid or prolonged exertion at work or recreation Grade 2: Slight limitation of ordinary activity. Walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, or in cold, or in wind, or under emotional stress, or only during the few hours after awakening. Walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal conditions Grade 3: Marked limitation of ordinary physical activity. Walking one or two blocks on the level and climbing one flight of stairs in normal conditions and at normal pace Grade 4: Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest A higher grade is a worse outcome.
  • Change From Baseline in Seattle Angina Questionnaire [ Time Frame: 6 months ]
    The SAQ quantifies patients' physical limitations caused by angina, the frequency of and recent changes in their symptoms, their satisfaction with treatment, and the degree to which they perceive their disease to affect their quality of life. Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
  • Change From Baseline in SF-36 Scores [ Time Frame: 6 months ]
    The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2018)
  • Change from baseline in microvascular function as assessed by intracoronary administration of acetylcholine and nitroglycerin [ Time Frame: Day 180 ]
  • Change from baseline in peripheral arterial tonometry [ Time Frame: Day 180 ]
  • Proportion of subjects with adverse events [ Time Frame: Day 365 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
Official Title  ICMJE An Open-Label Exploratory Clinical Study to Evaluate the Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction (CMD) and Without Obstructive Coronary Artery Disease
Brief Summary This clinical trial will explore the safety and effect of GCSF-mobilized autologous ex vivo selected CD34 cells for the treatment of CMD in adults currently experiencing angina and with no obstructive coronary artery disease. Eligible subjects will receive a single intracoronary infusion of CLBS16.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Microvascular Dysfunction
Intervention  ICMJE Biological: CLBS16
GCSF-mobilized autologous CD34 cells
Study Arms  ICMJE Experimental: Autologous CD34 cells
Open label active treatment arm. Subjects receive autologous CD34 cells.
Intervention: Biological: CLBS16
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2018)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 5, 2020
Actual Primary Completion Date December 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men or women age ≥18
  • History of and currently experiencing angina at least 3 times per week
  • No obstructive coronary artery disease
  • On stable medical therapy for 30 days prior to enrollment
  • Must agree to use a reliable and acceptable method of contraception for the duration of participation
  • Written informed consent

Exclusion Criteria:

  • Myocardial infarction within 90 days
  • Prior evidence of obstructive heart disease including PCI or CABG (or planned PCI or CABG)
  • Diagnosis of other specific cardiac disease
  • Must meet LVEF and GFR requirements
  • Current use of coumadin or DOACs
  • Hypersensitivity to G-CSF, apheresis or study product components
  • Positive for HIV, hepatitis B or hepatitis C
  • Active inflammatory or autoimmune disease, or chronic immunosuppressive state
  • Drug abuse
  • Pregnant or lactating
  • Malignant neoplasm within 5 years
  • History of Sickle Cell Disease
  • Participation in another clinical study within 90 days
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03508609
Other Study ID Numbers  ICMJE CLBS16-P01
1R44HL135889-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Lisata Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Lisata Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Cedars-Sinai Medical Center
  • Mayo Clinic
Investigators  ICMJE
Study Director: Douglas W. Losordo, MD Chief Medical Officer
PRS Account Lisata Therapeutics, Inc.
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP