Skip to main content

Table 3 Mesenchymal stem cell-derived exosomes in clinical trials (https://www.clinicaltrials.gov/)

From: Mesenchymal stem cell derived-exosomes: a modern approach in translational medicine

Organ

Condition/disease

Trial ID/Ref

Phase

Status

Source of exosomes

Dose/frequency/route

Location

Lung

Healthy

NCT04313647

I

Recruiting

AD-MSC

1× level: 2.0 × 108/3 ml

China

2× level: 4.0 × 108/3 ml

4× level: 8.0 × 108/3 ml

6× level: 12.0 × 108/3 ml

8× level: 16.0 × 108/3 ml

10× level: 20.0 × 108/3 ml

All experiments: once; aerosol inhalation

SARS-CoV-2 pneumonia

NCT04276987

I

Completed

AD-MSC

2.0 × 108/3 ml

China

Once a day during 5 days

 

Aerosol inhalation

NCT04491240

I, II

Enrolling by invitation

MSC

Procedure 1: 0.5–2 × 1010/3 ml

Russia

Procedure 2: 0.5–2 × 1010/3 ml

All experiments: twice a day during 10 days; inhalation

Bronchopulmonary dysplasia

NCT03857841

I

Recruiting

BM-MSC

20 pmol phospholid/kg

 

60 pmol phospholid/kg

200 pmol phospholid/kg

All experiments: intravenous injection

Skin

Dystrophic epidermolysis bullosa

NCT04173650

I, II

Not yet recruiting

BM-MSC

AGLE-102 exosomes

USA

Once a day during 60 days

Applied topically to the entire body

Chronic ulcer

NCT04134676

I

Completed

WJ-MSC

Conditioned medium gel

Indonesia

Every week for 2 weeks

Applied topically to the wound

Brain

Acute ischemic stroke

NCT03384433

I, II

Completed

BM-MSC

200 µg total protein of miR-124-loaded exosomes

Iran

One month after attack

Stereotactic guidance

Alzheimer’s disease

NCT04388982

I, II

Not yet recruiting

AD-MSC

Low dosage group: 5 μg exosome/1 ml

China

Mild dosage group: 10 μg exosome/1 ml

High dosage group: 20 μg exosome/1 ml

All experiments: twice a week during 12 weeks; nasal drip

Eye

Macular holes

NCT03437759

Early phase I

Recruiting

UC-MSC

20–50 µg exosome/10 μl

China

Single dose

Directly injected around macular hole area

Dry eye

NCT04213248

I, II

Recruiting

UC-MSC

10 µg exosome/drop

China

4 times a day during 14 days

Eye drops

Other organs/tissues

Multiple organ failure

NCT04356300

Not applicable

Not yet recruiting

UC-MSC

150 mg exosome

China

Once a day during 14 days

Intravenous injection

Diabetes mellitus type 1

NCT02138331

II, III

Unknown

UC-MSC

First dose: Intravenous injection of exosomes isolated from the supernatant produced from 1.22–1.51 × 106 MSCs/kg

Egypt

Second dose: 7 days after the first dose; intravenous injection of MVs isolated from the supernatant produced from the same dose of MSCs utilized in the first injection

Osteoarthritis

NCT04223622

I

Not yet recruiting

AD-MSC

Osteochondral explants from arthroplasty patients treated with AD-MSC secretome (either complete conditioned medium or EVs)

Italy

Graft-versus-host disease

[109]

–

Concluded

BM-MSC

1.3–3.5 × 1010 exosome/unit; 0.5–1.6 mg/unit (The yield of an EV fraction isolated from supernatants of 4 × 107 MSCs was defined as one unit.)

Germany

First dose: a tenth of a unit

Second dose: 2 days after the first dose, unit amounts were progressively enhanced and administered every 2–3 days until 4 doses

Chronic kidney disease

[110]

II, III

Concluded

UC-MSC

100 μg of total EV protein/kg

Egypt

2 doses (1 week apart)

First dose: intravenous injection

Second dose: infused into the renal artery