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

T

Tongji University

Status and phase

Withdrawn
Phase 2

Conditions

Long COVID-19

Treatments

Biological: UC-MSCs

Study type

Interventional

Funder types

Other

Identifiers

NCT05719012
DFSC-2023(CR)-02

Details and patient eligibility

About

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

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

0 participants in 2 patient groups, including a placebo group

UC-MSCs
Experimental group
Description:
UC-MSCs
Treatment:
Biological: UC-MSCs
Placebo
Placebo Comparator group
Description:
0.9% Normal Saline
Treatment:
Biological: UC-MSCs

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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