NCT05669144

Co-transplantation of Mesenchymal Stem Cell Derived Exosomes and Autologous Mitochondria for Patients Candidate for CABG Surgery

Status unknown Phase 1, PHASE2 Last updated 30 December 2022

What this trial tests

Phase 1, PHASE2 trial testing mitochondria and MSC-derived exosomes in Myocardial Infarction in 20 participants. Status unknown.

Timeline

20 April 2022

Primary endpoint
20 September 2023

20 September 2024

Quick facts

Lead sponsor	Tehran University of Medical Sciences
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	20
Start date	20 April 2022
Primary completion	20 September 2023
Estimated completion	20 September 2024
Sites	1 location across Iran

Drugs / interventions tested

• mitochondria and MSC-derived exosomes — full drug profile →

Conditions studied

• Myocardial Infarction — all drugs for Myocardial Infarction →
• Myocardial Ischemia — all drugs for Myocardial Ischemia →
• Myocardial Stunning — all drugs for Myocardial Stunning →

Sponsor

Tehran University of Medical Sciences

Who can join

Adults 35 to 80, any sex, with Myocardial Infarction or Myocardial Ischemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Heart failure (HF) and acute myocardial infarction that often follows are among the main causes of disability and death worldwide. As such, new treatments and biological drugs are needed to protect the heart against the harmful effects of ischemia and also reperfusion injury (IRI), preserve cardiac function, reduce the zone of myocardial infarction (MI), and improve patient outcomes. In this regard, it has been shown that mitochondrial dysfunction has a key role in the pathogenesis of heart ischemia, cardiomyopathy, and reperfusion injury. in this study which includes 4 groups of intervention, we try to minimize the damage by transplantation of mitochondria and administration of MSC-derived exosomes. MSC-derived exosomes limit inflammatory damage while fresh autologous exosomes limit oxidative stress.

Publications & conference data

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

1. Clinical applications of stem cell-derived exosomes.
   Tan F, Li X, Wang Z, Li J, et al · · 2024 · cited 390× · PMID 38212307 · DOI 10.1038/s41392-023-01704-0
2. Advances in the study of exosomes derived from mesenchymal stem cells and cardiac cells for the treatment of myocardial infarction.
   Liu Y, Wang M, Yu Y, Li C, et al · · 2023 · cited 51× · PMID 37580705 · DOI 10.1186/s12964-023-01227-9
3. Insight into the Functional Dynamics and Challenges of Exosomes in Pharmaceutical Innovation and Precision Medicine.
   Sharma A, Yadav A, Nandy A, Ghatak S. · · 2024 · cited 40× · PMID 38931833 · DOI 10.3390/pharmaceutics16060709
4. Mitochondria as secretory organelles and therapeutic cargos.
   Suh J, Lee YS. · · 2024 · cited 39× · PMID 38172601 · DOI 10.1038/s12276-023-01141-7
5. Understanding molecular characteristics of extracellular vesicles derived from different types of mesenchymal stem cells for therapeutic translation.
   Ding Z, Greenberg ZF, Serafim MF, Ali S, et al · · 2024 · cited 34× · PMID 38957857 · DOI 10.1016/j.vesic.2024.100034
6. Therapeutic Effects of Mesenchymal Stromal Cells Require Mitochondrial Transfer and Quality Control.
   Mukkala AN, Jerkic M, Khan Z, Szaszi K, et al · · 2023 · cited 31× · PMID 37958771 · DOI 10.3390/ijms242115788
7. Standardized Reporting of Research on Exosomes to Ensure Rigor and Reproducibility.
   Yadav A, Xuan Y, Sen CK, Ghatak S. · · 2024 · cited 28× · PMID 38888007 · DOI 10.1089/wound.2024.0093
8. Stem Cell-Based Acellular Therapy: Insight into Biogenesis, Bioengineering and Therapeutic Applications of Exosomes.
   Choudhery MS, Arif T, Mahmood R, Harris DT. · · 2024 · cited 26× · PMID 39062506 · DOI 10.3390/biom14070792