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

NCT06492798 | Recruiting Phase 1

• 1 other identifier: MSCinLong-COVID
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness and safety of mesenchymal stem cell therapy in long-COVID patients. The main questions it aims to answer include:

• whether umbilical cord mesenchymal stem cell therapy does benefit long-COVID patients
• whether umbilical cord mesenchymal stem cell therapy is safe for long-COVID patients. Participants' demographics, chief complaints, and vital signs will be collected and recorded. Basic physical examinations, bloodwork routine, biochemical indexes, oxygen saturation (SpO2) levels, 6-minute walk tests, high-resolution computed tomography (HRCT) scan (if necessary) results will be conducted. Participants will receive either an intravenous infusion of mesenchymal stem cells, or a placebo for one time. Participants' symptoms will be assessed on Day 28 of the trial. If there is no significant effect, an additional infusion will be given on Days 35-42, and the symptoms will be reassessed 28 days after that. Continuous nebulized inhalation of UCMSC-derived exosomes will be administered for 5 days twice daily to treatment group, with no treatment given to the control group. Researchers will compare data and information collected from the treatment and control groups to evaluate the safety and efficacy of UCMSC-derived exosomes for the treatment of chronic cough after COVID-19 infection.

Conditions

Long COVID; Post-Acute COVID-19 Syndrome

Keywords

Post-Acute COVID-19 Syndrome; Mesenchymal stem cell; Effectiveness; Safety

Outcome Measures

Primary Outcomes (1)

• Common Terminology Criteria for Adverse Events (CTCAE5.0)

  CTCAE is a descriptive terminology which can be used for Adverse Event (AE) reporting. An Adverse Event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Higher grades mean worse outcome.

  28th day

Secondary Outcomes (1)

• Common Terminology Criteria for Adverse Events (CTCAE5.0)

  12th week, 24th week

Other Outcomes (5)

• C reactive protein(CRP)

  28th day, 12th week, 24th week

• Dosage of corticosteroids

  28th day, 12th week, 24th week

• SpO2

  28th day, 12th week, 24th week

Study Arms (2)

Treatment group

EXPERIMENTAL

Participants will receive intravenous infusion of MSCs once or an additional infusion on days 35-42. Dosage: 1×10\^6 cells per kilogram of body weight Specification: 1×10\^7 cells/100ml

Drug: umbilical cord mesenchymal stem cell

Placebo group

PLACEBO COMPARATOR

Participants will receive intravenous infusion of placebo Dosage: 10ml per kilogram of body weight

Drug: umbilical cord mesenchymal stem cell

Interventions

umbilical cord mesenchymal stem cell DRUG

intravenous infusion of umbilical cord mesenchymal stem cell

Also known as: MSCs

Placebo group; Treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meeting the diagnostic criteria for Long COVID according to WHO.
• Main symptoms assessed based on CTCAE 5.0.
• No recent plans for pregnancy (negative pregnancy test within 72 hours for women of childbearing age prior to the start of the trial), and willing to use effective non-pharmaceutical contraceptive measures during the study.
• Signed informed consent forms and agreements to participate in this clinical trial.

You may not qualify if:

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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, 200433, China

RECRUITING

Related Publications (11)

• Soriano JB, Murthy S, Marshall JC, Relan P, Diaz JV; WHO Clinical Case Definition Working Group on Post-COVID-19 Condition. A clinical case definition of post-COVID-19 condition by a Delphi consensus. Lancet Infect Dis. 2022 Apr;22(4):e102-e107. doi: 10.1016/S1473-3099(21)00703-9. Epub 2021 Dec 21.

  PMID: 34951953 BACKGROUND

• Ledford H. Can drugs reduce the risk of long COVID? What scientists know so far. Nature. 2022 Apr;604(7904):20-21. doi: 10.1038/d41586-022-00823-y. No abstract available.

  PMID: 35338366 BACKGROUND

• Chen L, Qu J, Kalyani FS, Zhang Q, Fan L, Fang Y, Li Y, Xiang C. Mesenchymal stem cell-based treatments for COVID-19: status and future perspectives for clinical applications. Cell Mol Life Sci. 2022 Feb 20;79(3):142. doi: 10.1007/s00018-021-04096-y.

  PMID: 35187617 BACKGROUND

• Yousefi Dehbidi M, Goodarzi N, Azhdari MH, Doroudian M. Mesenchymal stem cells and their derived exosomes to combat Covid-19. Rev Med Virol. 2022 Mar;32(2):e2281. doi: 10.1002/rmv.2281. Epub 2021 Aug 7.

  PMID: 34363275 BACKGROUND

• Rebelatto CLK, Senegaglia AC, Franck CL, Daga DR, Shigunov P, Stimamiglio MA, Marsaro DB, Schaidt B, Micosky A, de Azambuja AP, Leitao CA, Petterle RR, Jamur VR, Vaz IM, Mallmann AP, Carraro Junior H, Ditzel E, Brofman PRS, Correa A. Safety and long-term improvement of mesenchymal stromal cell infusion in critically COVID-19 patients: a randomized clinical trial. Stem Cell Res Ther. 2022 Mar 21;13(1):122. doi: 10.1186/s13287-022-02796-1.

  PMID: 35313959 BACKGROUND

• Zhao F, Ma Q, Yue Q, Chen H. SARS-CoV-2 Infection and Lung Regeneration. Clin Microbiol Rev. 2022 Apr 20;35(2):e0018821. doi: 10.1128/cmr.00188-21. Epub 2022 Feb 2.

  PMID: 35107300 BACKGROUND

• Shi L, Wang L, Xu R, Zhang C, Xie Y, Liu K, Li T, Hu W, Zhen C, Wang FS. Mesenchymal stem cell therapy for severe COVID-19. Signal Transduct Target Ther. 2021 Sep 8;6(1):339. doi: 10.1038/s41392-021-00754-6.

  PMID: 34497264 BACKGROUND

• Meng F, Xu R, Wang S, Xu Z, Zhang C, Li Y, Yang T, Shi L, Fu J, Jiang T, Huang L, Zhao P, Yuan X, Fan X, Zhang JY, Song J, Zhang D, Jiao Y, Liu L, Zhou C, Maeurer M, Zumla A, Shi M, Wang FS. Human umbilical cord-derived mesenchymal stem cell therapy in patients with COVID-19: a phase 1 clinical trial. Signal Transduct Target Ther. 2020 Aug 27;5(1):172. doi: 10.1038/s41392-020-00286-5.

  PMID: 32855385 BACKGROUND

• Shi L, Yuan X, Yao W, Wang S, Zhang C, Zhang B, Song J, Huang L, Xu Z, Fu JL, Li Y, Xu R, Li TT, Dong J, Cai J, Li G, Xie Y, Shi M, Li Y, Zhang Y, Xie WF, Wang FS. Human mesenchymal stem cells treatment for severe COVID-19: 1-year follow-up results of a randomized, double-blind, placebo-controlled trial. EBioMedicine. 2022 Jan;75:103789. doi: 10.1016/j.ebiom.2021.103789. Epub 2021 Dec 25.

  PMID: 34963099 BACKGROUND

• Shi L, Huang H, Lu X, Yan X, Jiang X, Xu R, Wang S, Zhang C, Yuan X, Xu Z, Huang L, Fu JL, Li Y, Zhang Y, Yao WQ, Liu T, Song J, Sun L, Yang F, Zhang X, Zhang B, Shi M, Meng F, Song Y, Yu Y, Wen J, Li Q, Mao Q, Maeurer M, Zumla A, Yao C, Xie WF, Wang FS. 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. Signal Transduct Target Ther. 2021 Feb 10;6(1):58. doi: 10.1038/s41392-021-00488-5.

  PMID: 33568628 BACKGROUND

• Zhou T, Yuan Z, Weng J, Pei D, Du X, He C, Lai P. Challenges and advances in clinical applications of mesenchymal stromal cells. J Hematol Oncol. 2021 Feb 12;14(1):24. doi: 10.1186/s13045-021-01037-x.

  PMID: 33579329 BACKGROUND

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yuchao Dong, Doctor

  Changhai Hospital

  STUDY DIRECTOR

Central Study Contacts

Yuchao Dong, Doctor

CONTACT

+86 021-31161314; dongyc1020@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor.

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 9, 2024
• Study Start: September 1, 2023
• Primary Completion: July 1, 2025
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2-years
• Access Criteria: The requested data will be shared with investigators via a secured, password-protected software website

Locations

CN (1)