Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 70Years
All Genders
ID06492798

Effectiveness and Safety of Mesenchymal Stem Cell Therapy in Long COVID Patients

Led by Changhai Hospital · Updated on 2024-07-09

76

Participants Needed

1

Research Sites

60 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of mesenchymal stem cell therapy in patients with long COVID, a condition where symptoms persist for months after initial infection. This condition affects multiple organs and leads to symptoms like fatigue, trouble breathing, muscle pain, and insomnia. The study is a randomized, double-blind, placebo-controlled trial aiming to assess whether umbilical cord mesenchymal stem cell therapy benefits long COVID patients and whether it is safe for them. Participants will receive either an intravenous infusion of umbilical cord mesenchymal stem cells or a placebo. The initial infusion is given once, with a possible additional infusion between Days 35 and 42 if symptoms do not improve. The treatment group also receives continuous nebulized inhalation of UCMSC-derived exosomes twice daily for five days, while the control group receives no inhalation treatment. The trial includes two stages: the first with 10 patients receiving stem cells to primarily assess safety, and the second stage with 66 patients randomized evenly between treatment and control groups to evaluate effectiveness and safety. Participants will have their symptoms assessed using the Common Terminology Criteria for Adverse Events (CTCAE 5.0) at Day 28, and again at 12 and 24 weeks after treatment completion. Other assessments include demographics, vital signs, physical exams, blood tests, oxygen saturation levels, 6-minute walk tests, and high-resolution CT scans if needed. Researchers will monitor symptom improvement, adverse events, and safety. The study runs until August 2026 and involves thorough follow-up for up to 24 weeks after treatment.

CONDITIONS

Brief Title

Effectiveness and Safety of Mesenchymal Stem Cell Therapy in Long COVID Patients

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meeting the diagnostic criteria for Long COVID according to WHO
  • Main symptoms assessed based on CTCAE 5.0
  • Symptoms evaluated to exclude other diseases by relevant specialists
  • Negative pregnancy test within 72 hours before the trial for women of childbearing age
  • Willingness to use effective non-pharmaceutical contraception during the study
  • Signed informed consent and agreement to participate in the clinical trial
Not Eligible

You will not qualify if you...

  • Active malignant tumors
  • Active infections
  • Abnormal liver function (ALT, AST > 2 times upper limit of normal)
  • Abnormal kidney function (Creatinine > 2 times upper limit of normal)
  • Women who are pregnant, lactating, or planning pregnancy during the trial
  • Participation in other clinical trials within the last 3 months prior to screening
  • Other reasons deemed inappropriate for participation by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 6 weeks

Participants receive intravenous infusion of umbilical cord mesenchymal stem cells or placebo to evaluate the effectiveness and safety of the therapy for long COVID symptoms.

1 to 2 infusions over 6 weeks

Follow-up

Duration - 24 weeks

Participants are monitored to assess symptom improvement and safety through scheduled evaluations after treatment completion.

Visits at 28 days, 12 weeks, and 24 weeks after treatment

Trial Site Locations

Total: 1 location

1

Shanghai Changhai Hospital

Shanghai, China, 200433

Actively Recruiting

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Research Team

Y

Yuchao Dong, Doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Mesenchymal stem cell-based treatments for COVID-19: status and future perspectives for clinical applications.

Lijun Chen, Jingjing Qu, Farhin Shaheed Kalyani...

https://pubmed.ncbi.nlm.nih.gov/35187617

Safety and long-term improvement of mesenchymal stromal cell infusion in critically COVID-19 patients: a randomized clinical trial.

Carmen Lúcia Kuniyoshi Rebelatto, Alexandra Cristina Senegaglia, Claudio Luciano Franck...

https://pubmed.ncbi.nlm.nih.gov/35313959

Human mesenchymal stem cells treatment for severe COVID-19: 1-year follow-up results of a randomized, double-blind, placebo-controlled trial.

Lei Shi, Xin Yuan, Weiqi Yao...

https://pubmed.ncbi.nlm.nih.gov/34963099

Effect of human umbilical cord-derived mesenchymal stem cells on lung damage in severe COVID-19 patients: a randomized, double-blind, placebo-controlled phase 2 trial.

Lei Shi, Hai Huang, Xuechun Lu...

https://pubmed.ncbi.nlm.nih.gov/33568628