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Stem Cell Therapy

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

Phase 2
Waitlist Available
Research Sponsored by Lisata Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial is testing if using a patient's own stem cells can help adults with chest pain but no blocked arteries. The treatment aims to improve small blood vessels in the heart to reduce pain. Stem cell therapy has been explored for many years as a potential treatment for heart conditions, including heart attacks and heart failure.

Eligible Conditions
  • Coronary Artery Disease
  • Nephrotic Syndrome
  • Coronary Microvascular Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2020 Phase 2 trial • 20 Patients • NCT03508609
55%
Bone Pain
45%
Nausea
30%
Headache
30%
Pain
30%
Angina pectoris
25%
Dizziness
20%
Oropharyngeal pain
20%
Dyspnoea
20%
Paraesthesia oral
15%
Catheter site pain
15%
Upper respiratory tract infection
15%
Paraesthesia
15%
Hepatic enzyme increased
10%
Pyrexia
10%
Fatigue
10%
Back pain
5%
Syncope
5%
Ventricular fibrillation
5%
Coronary artery dissection
5%
Acute coronary syndrome
5%
Colon adenoma
5%
Hepatitis acute
5%
Vascular pseudoaneurysm
5%
Pain in extremity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Autologous CD34 Cells

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: GCSF-mobilized autologous CD34+ cellsExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CLBS16
2018
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

Lisata Therapeutics, Inc.Lead Sponsor
16 Previous Clinical Trials
1,338 Total Patients Enrolled
1 Trials studying Nephrotic Syndrome
20 Patients Enrolled for Nephrotic Syndrome
Caladrius Biosciences, Inc.Lead Sponsor
13 Previous Clinical Trials
1,198 Total Patients Enrolled
1 Trials studying Nephrotic Syndrome
20 Patients Enrolled for Nephrotic Syndrome
Robert Honigberg, MDStudy DirectorCaladrius Biosciences, Inc.
1 Previous Clinical Trials
24 Total Patients Enrolled
Kristen K Buck, MDStudy DirectorLisata Therapeutics, Inc.
3 Previous Clinical Trials
119 Total Patients Enrolled
~7 spots leftby Dec 2025
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