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Stem Cell Therapy

CLBS16 for Nephrotic Syndrome (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 baseline to 3 and 6 months
Awards & highlights

FREEDOM Trial Summary

This trial will study whether a cell therapy can improve symptoms in people with coronary microvascular disease who have angina and no blockages in their coronary arteries.

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

FREEDOM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3 and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in CCS angina class
Change from baseline in angina frequency
Change from baseline in health-related quality of life (HRQoL)
+1 more

Side effects data

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

FREEDOM 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
15 Previous Clinical Trials
1,308 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.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
CellsJournal
Angiogenic CD34 Stem Cell Therapy in Coronary Microvascular Repair—a Systematic Review
Rai, Balaj, Janki Shukla, Timothy D. Henry, and Odayme Quesada. 2021. “Angiogenic CD34 Stem Cell Therapy in Coronary Microvascular Repair—a Systematic Review”. Cells. MDPI AG. doi:10.3390/cells10051137.
clinicaltrials.govStudy
A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction
2020. "A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04614467.
~8 spots leftby Apr 2025
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