Trial Outcomes & Findings for A Tolerance Clinical Study on Aerosol Inhalation of Mesenchymal Stem Cells Exosomes In Healthy Volunteers (NCT NCT04313647)
NCT ID: NCT04313647
Last Updated: 2021-08-04
Results Overview
Safety evaluation within 7 days after first treatment, including frequency of adverse reaction (AE) and severe adverse reaction (SAE)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
from Day 0 to Day 7
Results posted on
2021-08-04
Participant Flow
Participant milestones
| Measure |
1X Level
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (2.0\*10E8 nano vesicles/3 ml)
1X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (2.0\*10E8 nano vesicles/3 ml)
|
2X Level
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (4.0\*10E8 nano vesicles/3 ml)
2X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (4.0\*10E8 nano vesicles/3 ml)
|
4X Level
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (8.0\*10E8 nano vesicles/3 ml)
4X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (8.0\*10E8 nano vesicles/3 ml)
|
6X Level
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (12.0\*10E8 nano vesicles/3 ml)
6X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (12.0\*10E8 nano vesicles/3 ml)
|
8X Level
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (16.0\*10E8 nano vesicles/3 ml)
8X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (16.0\*10E8 nano vesicles/3 ml)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
3
|
3
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Tolerance Clinical Study on Aerosol Inhalation of Mesenchymal Stem Cells Exosomes In Healthy Volunteers
Baseline characteristics by cohort
| Measure |
1X Level
n=3 Participants
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (2.0\*10E8 nano vesicles/3 ml)
1X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (2.0\*10E8 nano vesicles/3 ml)
|
2X Level
n=3 Participants
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (4.0\*10E8 nano vesicles/3 ml)
2X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (4.0\*10E8 nano vesicles/3 ml)
|
4X Level
n=6 Participants
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (8.0\*10E8 nano vesicles/3 ml)
4X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (8.0\*10E8 nano vesicles/3 ml)
|
6X Level
n=6 Participants
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (12.0\*10E8 nano vesicles/3 ml)
6X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (12.0\*10E8 nano vesicles/3 ml)
|
8X Level
n=6 Participants
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (16.0\*10E8 nano vesicles/3 ml)
8X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (16.0\*10E8 nano vesicles/3 ml)
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
26 years
n=5 Participants
|
26 years
n=7 Participants
|
25 years
n=5 Participants
|
25 years
n=4 Participants
|
25.5 years
n=21 Participants
|
25 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
|
Region of Enrollment
China
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
24 participants
n=8 Participants
|
|
Comorbidity
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Smoking history
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: from Day 0 to Day 7Safety evaluation within 7 days after first treatment, including frequency of adverse reaction (AE) and severe adverse reaction (SAE)
Outcome measures
| Measure |
1X Level
n=3 Participants
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (2.0\*10E8 nano vesicles/3 ml)
1X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (2.0\*10E8 nano vesicles/3 ml)
|
2X Level
n=3 Participants
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (4.0\*10E8 nano vesicles/3 ml)
2X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (4.0\*10E8 nano vesicles/3 ml)
|
4X Level
n=6 Participants
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (8.0\*10E8 nano vesicles/3 ml)
4X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (8.0\*10E8 nano vesicles/3 ml)
|
6X Level
n=6 Participants
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (12.0\*10E8 nano vesicles/3 ml)
6X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (12.0\*10E8 nano vesicles/3 ml)
|
8X Level
n=6 Participants
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (16.0\*10E8 nano vesicles/3 ml)
8X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (16.0\*10E8 nano vesicles/3 ml)
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Reaction (AE) and Severe Adverse Reaction (SAE)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 0 and day 7one of the indexes about liver function
Outcome measures
| Measure |
1X Level
n=3 Participants
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (2.0\*10E8 nano vesicles/3 ml)
1X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (2.0\*10E8 nano vesicles/3 ml)
|
2X Level
n=3 Participants
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (4.0\*10E8 nano vesicles/3 ml)
2X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (4.0\*10E8 nano vesicles/3 ml)
|
4X Level
n=6 Participants
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (8.0\*10E8 nano vesicles/3 ml)
4X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (8.0\*10E8 nano vesicles/3 ml)
|
6X Level
n=6 Participants
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (12.0\*10E8 nano vesicles/3 ml)
6X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (12.0\*10E8 nano vesicles/3 ml)
|
8X Level
n=6 Participants
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (16.0\*10E8 nano vesicles/3 ml)
8X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (16.0\*10E8 nano vesicles/3 ml)
|
|---|---|---|---|---|---|
|
Alanine Aminotransferase (ALT) (IU/L)
Day 0
|
16 IU/L
Interval 16.0 to 24.0
|
21 IU/L
Interval 8.0 to 30.0
|
24 IU/L
Interval 14.25 to 42.0
|
17.5 IU/L
Interval 9.75 to 21.25
|
15.5 IU/L
Interval 13.25 to 18.5
|
|
Alanine Aminotransferase (ALT) (IU/L)
Day 7
|
20 IU/L
Interval 16.0 to 21.0
|
24 IU/L
Interval 9.0 to 24.0
|
23.5 IU/L
Interval 13.25 to 58.25
|
16 IU/L
Interval 11.75 to 23.75
|
15.5 IU/L
Interval 11.0 to 18.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: day 0 and day 7One of the indexes about kidney function
Outcome measures
| Measure |
1X Level
n=3 Participants
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (2.0\*10E8 nano vesicles/3 ml)
1X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (2.0\*10E8 nano vesicles/3 ml)
|
2X Level
n=3 Participants
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (4.0\*10E8 nano vesicles/3 ml)
2X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (4.0\*10E8 nano vesicles/3 ml)
|
4X Level
n=6 Participants
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (8.0\*10E8 nano vesicles/3 ml)
4X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (8.0\*10E8 nano vesicles/3 ml)
|
6X Level
n=6 Participants
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (12.0\*10E8 nano vesicles/3 ml)
6X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (12.0\*10E8 nano vesicles/3 ml)
|
8X Level
n=6 Participants
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (16.0\*10E8 nano vesicles/3 ml)
8X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (16.0\*10E8 nano vesicles/3 ml)
|
|---|---|---|---|---|---|
|
Creatinine (Cr) (μmol/L)
Day 0
|
67 μmol/L
Interval 64.0 to 86.0
|
83 μmol/L
Interval 57.0 to 106.0
|
82.5 μmol/L
Interval 62.75 to 90.0
|
74.5 μmol/L
Interval 59.0 to 95.0
|
81 μmol/L
Interval 56.0 to 91.0
|
|
Creatinine (Cr) (μmol/L)
Day 7
|
64 μmol/L
Interval 59.0 to 86.0
|
77 μmol/L
Interval 67.0 to 115.0
|
86 μmol/L
Interval 63.25 to 92.75
|
74.5 μmol/L
Interval 64.75 to 86.25
|
80 μmol/L
Interval 56.5 to 90.0
|
Adverse Events
1X Level
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
2X Level
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
4X Level
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
6X Level
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
8X Level
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1X Level
n=3 participants at risk
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (2.0\*10E8 nano vesicles/3 ml)
1X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (2.0\*10E8 nano vesicles/3 ml)
|
2X Level
n=3 participants at risk
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (4.0\*10E8 nano vesicles/3 ml)
2X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (4.0\*10E8 nano vesicles/3 ml)
|
4X Level
n=6 participants at risk
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (8.0\*10E8 nano vesicles/3 ml)
4X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (8.0\*10E8 nano vesicles/3 ml)
|
6X Level
n=6 participants at risk
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (12.0\*10E8 nano vesicles/3 ml)
6X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (12.0\*10E8 nano vesicles/3 ml)
|
8X Level
n=6 participants at risk
Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (16.0\*10E8 nano vesicles/3 ml)
8X level of MSCs-Exo: Once aerosol inhalation of MSCs-derived exosomes (16.0\*10E8 nano vesicles/3 ml)
|
|---|---|---|---|---|---|
|
Cardiac disorders
Sinus bradycardia
|
33.3%
1/3 • Number of events 1 • 7days
|
0.00%
0/3 • 7days
|
0.00%
0/6 • 7days
|
0.00%
0/6 • 7days
|
16.7%
1/6 • Number of events 1 • 7days
|
Additional Information
Dr. Qu
Ruijin Hospital , Shanghai Jiao Tong University School of Medicine
Phone: (+86)2164370045
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place