NCT04661644

Efficacy and Safety of Mesenchymal Stem Cell Clusters in Patients with Critical Limb Ischemia

Completed Phase 1, PHASE2 Last updated 30 August 2024

What this trial tests

Phase 1, PHASE2 trial testing Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^7 cells/1 mL/vial) in Critical Limb Ischemia in 20 participants. Completed in 1 July 2024.

Timeline

4 November 2020

Primary endpoint
22 April 2024

1 July 2024

Quick facts

Lead sponsor	S.Biomedics Co., Ltd.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	4 November 2020
Primary completion	22 April 2024
Estimated completion	1 July 2024
Sites	1 location across South Korea

Drugs / interventions tested

• Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^7 cells/1 mL/vial) — full drug profile →
• Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^8 cells/1 mL/vial) — full drug profile →

Conditions studied

• Critical Limb Ischemia — all drugs for Critical Limb Ischemia →

Sponsor

S.Biomedics Co., Ltd. — full company profile →

Who can join

19 and older, any sex, with Critical Limb Ischemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This clinical trial is designed as a Phase 1/2a clinical trial targeting patients with critical limb ischemia. The trial is composed of Phase 1 to assess the tolerability and safety and Phase 2a to assess the safety and efficacy of the investigational product(A cluster of adipose-derived mesenchymal stem cells (3D-A) (cluster of adipose- derived mesenchymal stem cells)) and proceeds in that order.

Publications & conference data

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

1. Adipose Tissue-Derived Mesenchymal Stem/Stromal Cells and Their Contribution to Angiogenic Processes in Tissue Regeneration.
   Krawczenko A, Klimczak A. · · 2022 · cited 64× · PMID 35269568 · DOI 10.3390/ijms23052425
2. Mesenchymal stem cell-based therapy for non-healing wounds due to chronic limb-threatening ischemia: A review of preclinical and clinical studies.
   Huerta CT, Voza FA, Ortiz YY, Liu ZJ, et al · · 2023 · cited 36× · PMID 36818343 · DOI 10.3389/fcvm.2023.1113982
3. Emerging roles of mesenchymal stem cell therapy in patients with critical limb ischemia.
   Shirbaghaee Z, Hassani M, Heidari Keshel S, Soleimani M. · · 2022 · cited 36× · PMID 36068595 · DOI 10.1186/s13287-022-03148-9
4. The Clinical Trials of Mesenchymal Stromal Cells Therapy.
   Kouchakian MR, Baghban N, Moniri SF, Baghban M, et al · · 2021 · cited 30× · PMID 34745268 · DOI 10.1155/2021/1634782
5. Cell Therapy of Severe Ischemia in People with Diabetic Foot Ulcers-Do We Have Enough Evidence?
   Dubský M, Husáková J, Sojáková D, Fejfarová V, et al · · 2023 · cited 5× · PMID 37740111 · DOI 10.1007/s40291-023-00667-w
6. Emerging Strategies for Revascularization: Use of Cell-Derived Extracellular Vesicles and Artificial Nanovesicles in Critical Limb Ischemia.
   Ravi Mythili VM, Rajendran RL, Arun R, Thasma Loganathbabu VK, et al · · 2025 · cited 4× · PMID 39851366 · DOI 10.3390/bioengineering12010092
7. Therapeutic Potential of Adipose-Derived Regenerative Cells for Ischemic Diseases.
   Che Y, Shimizu Y, Murohara T. · · 2025 · cited 1× · PMID 40072072 · DOI 10.3390/cells14050343
8. Tissue regenerative medicine: Clinical advances, challenges, and opportunities.
   Badawy S, Gopinath V, Espinosa AMD, Suthiwanich K, et al · · 2025 · PMID 41424914 · DOI 10.1063/5.0296897