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Table 1 Clinical trials in Exosomes Therapy In Respiratory Diseases

From: Therapeutic role of mesenchymal stem cell-derived exosomes in respiratory disease

No

Title and sponsor

Trial ID

Location

Design

Primary outcome

Recruitment status

Phase

1.

The use of exosomes for the treatment of acute respiratory distress syndrome or novel coronavirus pneumonia caused by COVID-19 (ARDOXSO)

Sponsor: AVEM HealthCare

NCT04798716

United States, California

Open label, interventional, mesenchymal stem cell exosomes for the treatment of COVID-19 positive patients with acute respiratory distress syndrome and/or novel coronavirus pneumonia

N:55

Measure and report the number of participants with treatment-related-adverse events

Tabulate and report the number of IMV days for patients receiving ARDOXSO™ perinatal MSC-derived exosome therapy

Not yet recruiting

July 21, 2021

Phase 1

Phase 2

2.

Safety and efficiency of method of exosome inhalation in COVID-19 associated pneumonia (COVID-19EXO2)

Sponsor: Olga Tyumina

NCT04602442

Russian, Samara

Randomized, interventional, the extended protocol of evaluation of safety and efficiency of method of exosome inhalation in COVID-19 associated two-sided pneumonia

N: 90

Number of participants with non-serious and serious adverse events during trial

Number of participants with non-serious and serious adverse during inhalation procedure

Enrolling by invitation

October 26, 2020

Phase 2

3.

Evaluation of safety and efficiency of method of exosome inhalation in SARS-CoV-2 associated pneumonia. (COVID-19EXO)

Sponsor: State-Financed Health Facility “Samara Regional Medical Center Dinasty”

NCT04491240

Russian, Samara

Randomized, interventional, the protocol of evaluation of safety and efficiency of method of exosome inhalation in SARS-CoV-2 associated two-sided pneumonia

N: 30

Number of participants with non-serious and serious adverse events during trial

Number of participants with non-serious and serious adverse during inhalation procedure

Completed

November 4, 2020

Phase 1

Phase 2

4.

A safety study of IV stem cell-derived extracellular vesicles (UNEX-42) in preterm neonates at high risk for BPD

Sponsor: United Therapeutics

NCT03857841

United States, Colorado, Massachusetts, Mississippi, Missouri

Randomized, interventional, a safety study of intravenous infusion of bone marrow mesenchymal stem cell-derived extracellular vesicles (UNEX-42) in preterm neonates at high risk for bronchopulmonary dysplasia

N: 3

Number of subjects with treatment-emergent adverse events during the post-treatment phase

Terminated

October 12, 2021

Phase 1

5.

A clinical study of mesenchymal stem cell exosomes nebulizer for the treatment of ARDS

Sponsor: Ruijin Hospital

NCT04602104

China, Shanghai

Randomized, double-blinded, controlled clinical study of allogeneic human mesenchymal stem cell exosomes (hMSC-Exos) nebulized inhalation in the treatment of acute respiratory distress syndrome

N:169

Incidence of adverse reaction

Time to clinical improvement

28-day mortality

Recruiting

November 2, 2021

Phase 1

Phase 2

6.

A tolerance clinical study on aerosol inhalation of mesenchymal stem cells exosomes in healthy volunteers

Sponsor: Ruijin Hospital

NCT04313647

China, Shanghai

Open label, non randomized, interventional, a tolerance clinical study on aerosol inhalation of mesenchymal stem cells exosomes in healthy volunteers

N: 24

Number of Participants With Adverse Reaction (AE) and severe adverse reaction (SAE)

Completed

August 4, 2021

Phase 1

7.

Omics sequencing of exosomes in body fluids of patients with acute lung injury

Sponsor: Nanfang Hospital of Southern Medical University

NCT05058768

China, Guangdong

Observational, case–control, exosomes in urine, blood, and alveolar lavage fluid from patients with acute respiratory distress syndrome (ADRS) were sequenced by omics

N:180

Compare the omics differences of blood samples between the experimental and control groups

Compare the omics differences of urine samples between the experimental and control groups

Recruiting

September 28, 2021

Case–Control

8.

Exosomes derived from placental mesenchymal stem cells as treatment for severe COVID-19: Phase 1 and 2 clinical trials

Sponsor: Omid Cell and Tissue center

IRCT20200413047063N2

Tehran, Iran

Participants were randomly divided into two equal groups using a randomized double AB blocking method based on a random number table. Patients allocated randomly to two groups: (1) Intervention 1, Patients will receive Six doses of Exosomes. (2) Control, Patients will receive conventional therapy

N:50

Adverse events assessment

Recruiting

July 8, 2021

Phase 1

Phase 2

9.

Molecular profiling of exosomes in tumor-draining vein of early-staged lung cancer (ExOnSite-Pro)

Sponsor: University Hospital, Limoges

NCT04939324

France, Limoges

Open label, single group assignment, Analyse du Profil moléculaire Des Exosomes de la Veine Pulmonaire Dans le Cancer Bronchique de Stade précoce

N:30

Evaluate size distribution, concentration and molecular profiling of pulmonary vein exosomes at inclusion

Recruiting

November 11, 2021

Not applicable

10.

A pilot clinical study on inhalation of mesenchymal stem cells exosomes treating severe novel coronavirus pneumonia

Sponsor: Ruijin Hospital

NCT04276987

China, Shanghai

Open label, single group assignment, a pilot clinical study on aerosol inhalation of the exosomes derived from allogenic adipose mesenchymal stem cells in the treatment of severe patients with novel coronavirus pneumonia

N:24

Adverse reaction (AE) and severe adverse reaction (SAE)

Time to clinical improvement (TTIC)

Completed

September 7, 2020

Phase 1

11.

Extracellular vesicle infusion treatment for COVID-19 Associated ARDS (EXIT-COVID19)

Sponsor: Direct Biologics, LLC

NCT04493242

United States, Alabama, California, Pennsylvania, Texas

Randomized, double-blinded, bone marrow mesenchymal stem cell derived extracellular vesicles infusion treatment for COVID-19 associated acute respiratory distress syndrome (ARDS): a phase II clinical trial

N: 120

7 day change in partial pressure of arterial oxygen to fraction of inspired oxygen ratio

Completed

December 6, 2021

Phase 2

12.

Safety and efficacy of exosomes overexpressing CD24 in two doses for patients with moderate or severe COVID-19

Sponsor: Athens Medical Society

NCT04902183

Greece, Athens, Attica

Randomized, single, a Phase II randomized, single-blind dose study to evaluate the safety and efficacy of exosomes overexpressing CD24 in 10^9 dose versus 10^10 dose, for the prevention of clinical deterioration in patients with moderate or severe COVID-19

N:90

Collection of serious adverse events

Proportion of patients related with Respiratory rate and SpO2 saturation

Recruiting

June 15, 2021

Phase 2