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

• Sponsor: Caladrius Biosciences, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04614467
• Collaborator: (none)
• Enrollment: 105
• Locations: 7
• Arms: 2
• Anticipated Duration (Months): 31.1
• Patients Per Site: 15
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Microvascular Dysfunction; Coronary Microvascular Disease; Microvascular Coronary Artery Disease	Biological: CLBS16; Biological: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 28, 2020
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GCSF-mobilized autologous CD34+ cells	Biological: CLBS16; GCSF-mobilized autologous CD34+ cells
Placebo Comparator: Placebo	Biological: Placebo; isotonic solution (no CD34+ cells)

Outcome Measures

Primary Outcome Measures

1. Change from baseline in angina frequency [Baseline to 3 and 6 months]

2. Change from baseline in CCS angina class [Baseline to 3 and 6 months]

3. Change from baseline in total exercise time [Baseline to 6 months]

4. Change from baseline in health-related quality of life (HRQoL) [Baseline to 3 and 6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
2	University of Florida - College of Medicine/ div of Cardiovascular Medicine	Gainesville	Florida	United States	32606
3	Memorial Regional Hospital	Hollywood	Florida	United States	33021
4	Emory University Hospital	Atlanta	Georgia	United States	30322
5	Minneapolis Heart Institute at Abbott Northwestern Hospital	Minneapolis	Minnesota	United States	55407
6	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905
7	The Christ Hospital	Cincinnati	Ohio	United States	45219

Sponsors and Collaborators

• Caladrius Biosciences, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Caladrius Biosciences, Inc.
• ClinicalTrials.gov Identifier: NCT04614467
• Other Study ID Numbers: CLBS16-P02
• First Posted: Nov 4, 2020
• Last Update Posted: Jul 13, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Caladrius Biosciences, Inc.: angina; CMD; MVD; non-obstructive coronary artery disease
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Microvascular Angina

Study Results

No Results Posted as of Jul 13, 2022