Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Long COVID-19

Long COVID-19 Clinical Trial

Official title:

Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Long COVID-19: a Randomized, Double-blind, Parallel-controlled Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05719012
• Other study ID #: DFSC-2023(CR)-02
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 1, 2023
• Est. completion date: March 30, 2024

Study information

• Verified date: November 2023
• Source: Shanghai East Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To explore the efficacy and safety of Umbilical cord mesenchymal stem cells in the treatment of long COVID-19

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 30, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. The age ranges from 18 to 85 (inclusive), regardless of gender.

2. Patients with Confirmed SARS-CoV-2 infection, according to the consensus of the Chinese diagnostic criteria for COVID-19 (Tentative tenth Edition).

3. Patients with symptoms of long COVID-19 3 months from the onset of COVID-19, lasting for at least 2 months, and the symptoms cannot be explained by other diseases.

4. Be expected to live longer than 1 year.

5. Volunteer to participate in this clinical study and sign the written informed consent.

Exclusion Criteria:

1. Those who are using immunosuppressive drugs or long-term immunosuppressive drugs after organ transplantation.

2. T lymphocyte abnormality, HIV positive.

3. Highly allergic or have a history of severe allergy.

4. Pregnant and lactating women.

5. Patients with severe autoimmune disease history;

6. Patients with uncontrolled chronic diseases or serious complications;

7. Patients with malignant tumors;

8. Patients with pulmonary embolism, acute coronary syndrome, cerebral embolism or at high risk of thromboembolism;

9. Patients with severe organ dysfunction

10. Other situations that the researchers think are not suitable for participating in this study

Related Conditions & MeSH terms

• COVID-19
• Long COVID-19

Intervention

Biological:
• UC-MSCs
Intravenous injection three times with one-month interval

Locations

Country	Name	City	State
China	Shanghai East Hosptial	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai East Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six min walking distances	The maximum distance a person can walk in 6 min and acts as an endurance walking measure.	Changes from baseline index at Day 30, Day 60, Day 90 and Day 180
Primary	Lung function	The lung function assessed using FEV1, FEV1/FVC and DLco	Changes from the baseline index at Day 30, Day 60, Day 90 and Day 180
Secondary	Changes of the levels of Inflammatory cytokines	The levels of Inflammatory cytokines	Changes from the baseline levels at Day 30, Day 60, Day 90 and Day 180
Secondary	Changes of the scores of Multidimensional Fatigue Inventory	The degree of fatigue	Changes from the baseline scores at Day 30, Day 60, Day 90 and Day 180