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A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction (FREEDOM)

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: NCT04614467
Recruitment Status : Active, not recruiting
First Posted : November 4, 2020
Last Update Posted : July 13, 2022
Sponsor:
Information provided by (Responsible Party):
Lisata Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE October 29, 2020
First Posted Date  ICMJE November 4, 2020
Last Update Posted Date July 13, 2022
Actual Study Start Date  ICMJE October 28, 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2021)
  • Change from baseline in angina frequency [ Time Frame: Baseline to 3 and 6 months ]
  • Change from baseline in CCS angina class [ Time Frame: Baseline to 3 and 6 months ]
  • Change from baseline in total exercise time [ Time Frame: Baseline to 6 months ]
  • Change from baseline in health-related quality of life (HRQoL) [ Time Frame: Baseline to 3 and 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 29, 2020)
  • Change from baseline in peak coronary flow reserve [ Time Frame: Baseline to 6 months ]
  • Change from baseline in angina frequency [ Time Frame: Baseline to 3 and 6 months ]
  • Change from baseline in total exercise time [ Time Frame: Baseline to 6 months ]
  • Change from baseline in health-related quality of life (HRQoL) [ Time Frame: Baseline to 3 and 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction
Official Title  ICMJE A Double-Blind, Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of CLBS16 in Subjects With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease
Brief Summary This clinical trial will explore the efficacy and safety of GCSF-mobilized autologous 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 administration of CLBS16 or placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Microvascular Dysfunction
  • Coronary Microvascular Disease
  • Microvascular Coronary Artery Disease
Intervention  ICMJE
  • Biological: CLBS16
    GCSF-mobilized autologous CD34+ cells
  • Biological: Placebo
    isotonic solution (no CD34+ cells)
Study Arms  ICMJE
  • Experimental: GCSF-mobilized autologous CD34+ cells
    Intervention: Biological: CLBS16
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
Publications * Rai B, Shukla J, Henry TD, Quesada O. Angiogenic CD34 Stem Cell Therapy in Coronary Microvascular Repair-A Systematic Review. Cells. 2021 May 8;10(5). pii: 1137. doi: 10.3390/cells10051137. Review.

*   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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 29, 2020)
105
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date December 2022   (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
  • Prior diagnosis of CMD based on coronary flow reserve (CFR) ≤ 2.5 or other measures
  • Canadian Cardiovascular Society (CCS) class II, III or IV chronic refractory angina
  • No obstructive coronary artery disease
  • On stable medical therapy for at least 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 GCSF, 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 prior to informed consent or concurrently with this study
  • Previous treatment with a CD34+ cell based therapy
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 NCT04614467
Other Study ID Numbers  ICMJE CLBS16-P02
Has Data Monitoring Committee Yes
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 Not Provided
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 Not Provided
Investigators  ICMJE
Study Director: Kristen K Buck, MD Lisata Therapeutics, Inc.
PRS Account Lisata Therapeutics, Inc.
Verification Date July 2022

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