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Safety and Potential Bioactivity of CLBS16 in Patients With Coronary Microvascular Dysfunction and Without Obstructive Coronary Artery Disease

L

Lisata Therapeutics

Status and phase

Completed
Phase 2

Conditions

Coronary Microvascular Dysfunction

Treatments

Biological: CLBS16

Study type

Interventional

Funder types

Other
Industry
NIH

Identifiers

NCT03508609
1R44HL135889-01 (U.S. NIH Grant/Contract)
CLBS16-P01

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Autologous CD34 cells
Experimental group
Description:
Open label active treatment arm. Subjects receive autologous CD34 cells.
Treatment:
Biological: CLBS16

Trial documents
2

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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