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

NCT05669144 | Unknown Phase 1 DMC

• 1 other identifier: IR.TUMS.THC.REC.1401.025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myocardial Infarction; Myocardial Ischemia; Myocardial Stunning

Outcome Measures

Primary Outcomes (2)

• ejection fraction

  left ventricle ejection fraction

  3 months

• allergic reactions

  reactions including angioedema, hypotention, acute allergic reaction

  3 months

Secondary Outcomes (7)

• CK-MB

  2 week

• cTnT

  2 week

• on pump duration

  during the surgery

• ECMO duration

  duration after surgery if needed

• SPECT

  1 and 3 months post surgery

Study Arms (4)

exosome therapy

EXPERIMENTAL

a) Intracoronary and intra-myocardial injection of exosomes (5 patients) 1 mL of exosomes containing 100 micrograms of exosomes

Biological: mitochondria and MSC-derived exosomes

mitochondria therapy

EXPERIMENTAL

b) Intracoronary and intra-myocardial injection of mitochondria (5 patients) 1 mL of exosomes containing 10 million mitochondria

Biological: mitochondria and MSC-derived exosomes

co-transplantation of mitochondria and exosome therapy

EXPERIMENTAL

c) co-transplantation Intracoronary and intra-myocardial injection of exosomes and mitochondria (5 patients) 1 mL of exosomes containing 100 micrograms of exosomes 1 mL of exosomes containing 10 million mitochondria

Biological: mitochondria and MSC-derived exosomes

placebo

PLACEBO COMPARATOR

1 mL of placebo solution

Biological: mitochondria and MSC-derived exosomes

Interventions

mitochondria and MSC-derived exosomes BIOLOGICAL

autologous mitochondria and MSC-derived exosomes

co-transplantation of mitochondria and exosome therapy; exosome therapy; mitochondria therapy; placebo

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are candidate for CABG due to CAD±MR
• History of Q-wave MI, less than one month
• Age: 35-80
• LVEF \<=25% (by any imaging modality: echocardiography/SPECT/LV angiography and Cardiac MRI)
• Viability study as evidenced by low-dose dobutamine stress echocardiogram and/or or thallium redistribution nuclear study (at least four viable segments).

You may not qualify if:

• Severe co-morbidities (e.g., renal failure, liver failure, etc.)
• Inability to provide informed consent
• Cerebral Damage

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Tehran University of Medical Sciences

Tehran, 1411713138, Iran

RECRUITING

MeSH Terms

Conditions

Myocardial Infarction; Myocardial Ischemia; Myocardial Stunning

Interventions

Genes, Mitochondrial

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Genes; Genome Components; Genome; Genetic Structures; Genetic Phenomena; Extrachromosomal Inheritance; Inheritance Patterns

Study Officials

• alireza hadizadeh, M.D

  Tehran University of Medical Sciences

  STUDY CHAIR

Central Study Contacts

hossein ahmadi tafti

CONTACT

+989121153540; hosseinahmaditafti@yahoo.com

mohsen ahmadi tafti

CONTACT

+989122109773; smohsenahmadi1364@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 1. Intracoronary and intra-myocardial injection of exosomes (5 patients) 2. Intracoronary and intra-myocardial injection of mitochondria (5 patients) 3. Intracoronary and intra-myocardial injection of exosomes and mitochondria (5 patients) 4. Placebo (5 patients)

Study Record Dates

• First Submitted: December 10, 2022
• First Posted: December 30, 2022
• Study Start: April 20, 2022
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2024
• Last Updated: December 30, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)