NCT04614467: FREEDOM

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

Terminated Phase 2 Last updated 17 October 2023

What this trial tests

Phase 2 trial testing CLBS16 in Coronary Microvascular Dysfunction in 34 participants. Terminated before completion.

Timeline

29 October 2020

Primary endpoint
28 September 2022

28 September 2022

Quick facts

Lead sponsor	Lisata Therapeutics, Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	34
Start date	29 October 2020
Primary completion	28 September 2022
Estimated completion	28 September 2022
Sites	7 locations across United States

Drugs / interventions tested

• CLBS16 — full drug profile →
• Placebo

Conditions studied

• Coronary Microvascular Dysfunction — all drugs for Coronary Microvascular Dysfunction →
• Coronary Microvascular Disease — all drugs for Coronary Microvascular Disease →
• Microvascular Coronary Artery Disease — all drugs for Microvascular Coronary Artery Disease →

Sponsor

Lisata Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with Coronary Microvascular Dysfunction or Coronary Microvascular Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ischemia and no obstructive coronary arteries (INOCA): A narrative review.
   Mehta PK, Huang J, Levit RD, Malas W, et al · · 2022 · cited 77× · PMID 36423427 · DOI 10.1016/j.atherosclerosis.2022.11.009
2. Coronary Arterial Function and Disease in Women With No Obstructive Coronary Arteries.
   Reynolds HR, Bairey Merz CN, Berry C, Samuel R, et al · · 2022 · cited 55× · PMID 35175840 · DOI 10.1161/circresaha.121.319892
3. Ischemia and no obstructive coronary arteries in patients with stable ischemic heart disease.
   Mehta PK, Quesada O, Al-Badri A, Fleg JL, et al · · 2022 · cited 23× · PMID 34902504 · DOI 10.1016/j.ijcard.2021.12.013
4. Myocardial regeneration protocols towards the routine clinical scenario: An unseemly path from bench to bedside.
   Salerno N, Salerno L, Marino F, Scalise M, et al · · 2022 · cited 21× · PMID 35799845 · DOI 10.1016/j.eclinm.2022.101530
5. Angiogenic CD34 Stem Cell Therapy in Coronary Microvascular Repair-A Systematic Review.
   Rai B, Shukla J, Henry TD, Quesada O. · · 2021 · cited 19× · PMID 34066713 · DOI 10.3390/cells10051137
6. INOCA/ANOCA: Mechanisms and novel treatments.
   Ashokprabhu ND, Quesada O, Alvarez YR, Henry TD. · · 2023 · cited 14× · PMID 37377840 · DOI 10.1016/j.ahjo.2023.100302
7. Coronary Microvascular Dysfunction: Insights on Prognosis and Future Perspectives.
   Gurgoglione FL, Benatti G, Denegri A, Donelli D, et al · · 2025 · cited 5× · PMID 39867196 · DOI 10.31083/rcm25757
8. Stem Cell Therapy Targets: Repêchage!
   Bairey Merz CN, Marbán E. · · 2022 · cited 3× · PMID 35113658 · DOI 10.1161/circresaha.121.320663