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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04614467
Other study ID # CLBS16-P02
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 29, 2020
Est. completion date September 28, 2022

Study information

Verified date October 2023
Source Lisata Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 34
Est. completion date September 28, 2022
Est. primary completion date September 28, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Emory University Hospital Atlanta Georgia
United States The Christ Hospital Cincinnati Ohio
United States University of Florida - College of Medicine/ div of Cardiovascular Medicine Gainesville Florida
United States Memorial Regional Hospital Hollywood Florida
United States Cedars-Sinai Medical Center Los Angeles California
United States Minneapolis Heart Institute at Abbott Northwestern Hospital Minneapolis Minnesota
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Lisata Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in angina frequency Baseline to 3 and 6 months
Primary Change from baseline in CCS angina class Baseline to 3 and 6 months
Primary Change from baseline in total exercise time Baseline to 6 months
Primary Change from baseline in health-related quality of life (HRQoL) Baseline to 3 and 6 months
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