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

• ClinicalTrials.gov Identifier: NCT04614467
• Recruitment Status: Active, not recruiting
• First Posted: November 4, 2020
• Last Update Posted: July 13, 2022
• Sponsor: Caladrius Biosciences, Inc.
• Information provided by (Responsible Party): Caladrius Biosciences, Inc.

Tracking Information

• First Submitted Date: October 29, 2020
• First Posted Date: November 4, 2020
• Last Update Posted Date: July 13, 2022
• Actual Study Start Date: October 28, 2020
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Coronary Microvascular Dysfunction
• Coronary Microvascular Disease
• Microvascular Coronary Artery Disease

Intervention

• Biological: CLBS16
  GCSF-mobilized autologous CD34+ cells
• Biological: Placebo
  isotonic solution (no CD34+ cells)

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: October 29, 2020): 105
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2023
• Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04614467
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Caladrius Biosciences, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Caladrius Biosciences, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Kristen K Buck, MD; Caladrius Biosciences, Inc.

• PRS Account: Caladrius Biosciences, Inc.
• Verification Date: July 2022