Application and Research of Mesenchymal Stem Cells in Alleviating Severe Development of COVID-19 Infection

NCT05741099 | Unknown Phase 1 DMC

• 1 other identifier: 2023-MSCs-COVID-19
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the safety and efficacy of umbilical cord mesenchymal stem cells Therapy for COVID-19.

Conditions

COVID-19

Keywords

MSC; COVID-19

Outcome Measures

Primary Outcomes (1)

• Effectiveness evaluation

  The incidence and clinical status of progression to critical type after the third stem cell transplantation were evaluated

  Within 1 year of receiving mesenchymal stem cell transplants

Secondary Outcomes (8)

• Hospitalization time

  Time period from patient admission to discharge

• oxygenation index（OI）

  At the time of our patient's hospitalization and 7 days after receiving the third MSC transplant.

• Oxygen saturation（SaO2）

  At the time of our patient's hospitalization and 7 days after receiving the third MSC transplant.

• Chest CT

  At admission, before to the stem cell transplant, and at 1 month, 6 months, and 12 months following the third MSC transplant.

• Pulmonary function evaluation

  At admission, before to the stem cell transplant, and at 1 month, 6 months, and 12 months following the third MSC transplant.

Study Arms (2)

MSCs group

EXPERIMENTAL

Patient in Mscs group will receive MSCs implantation by intravenous injection Within 10-15 days of infection

Biological: Umbilical cord mesenchymal stem cells implantation

comparator

PLACEBO COMPARATOR

Patients in comparator group will receive placebo treatment Within 10-15 days of infection

Other: Comparator

Interventions

Umbilical cord mesenchymal stem cells implantation BIOLOGICAL

Patient in Mscs group will receive MSCs implantation by intravenous injection.

MSCs group

Comparator OTHER

Patients in comparator group will receive placebo treatment

comparator

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-85 years;The diagnosis of COVID-19 infection was clinically classified as Moderate cases, and the criteria were based on Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia(Trial Version 10)
• Having the relevant clinical manifestations of COVID-19 infection.
• Having one or more of the following etiological and serological examination results
• Tested positive for Novel Coronavirus nucleic acid
• Tested positive for Novel Coronavirus antigen
• Novel Coronavirus was isolated and cultured positive
• Novel Coronavirus specific immunoglobulin G reaches a titration of at least 4-fold increase during convalescence compared with the acute phase.
• Moderate cases diagnostic criteria：Persistent high fever \> 3 days or (and) cough, Tachypnea etc，but respiratory rate≧30 breaths/ min ,oxygen saturation \> 93% on finger pulse oximeter taken at rest. Radiology shows the characteristic manifestations of COVID-19 pneumonia
• There are one or more of the following risk factors for the development of severe / critical severity:
• Patients over 65 years old, especially those who have not been vaccinated against novel coronavirus
• Patients with cardiovascular and cerebrovascular diseases (including hypertension), chronic lung disease, diabetes, chronic liver and kidney disease, tumors and other underlying diseases, as well as maintenance dialysis
• Patients with immune deficiency (such as AIDS, long-term use of corticosteroids or other immunosuppressive drugs resulting in immune dysfunction)
• Patients with Obesity (body mass index ≥30)
• late trimester of pregnancy and perinatal women
• Heavy smoker.

You may not qualify if:

• Patients with prior or present tumor history,or precancerous lesions confirmed by pathological examination.
• Patients with active acute myocardial infarction or acute cerebral infarction.
• Pregnant or lactating patients.
• Patients with poorly controlled mental illness.
• Patients addicted to alcohol or drugs.
• Patients Unable or unwilling to sign informed consent or poor compliance.
• Patients with active tuberculosis or influenza virus, adenovirus and other acute respiratory virus infection.
• Patients deemed unsuitable for stem cell therapy by clinicians.
• Patients enrolled in other clinical trials within 3 months.

Sponsors & Collaborators

• Hebei Medical University: lead

Study Sites (1)

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050030, China

RECRUITING

Related Publications (9)

• Munster VJ, Koopmans M, van Doremalen N, van Riel D, de Wit E. A Novel Coronavirus Emerging in China - Key Questions for Impact Assessment. N Engl J Med. 2020 Feb 20;382(8):692-694. doi: 10.1056/NEJMp2000929. Epub 2020 Jan 24. No abstract available.

  PMID: 31978293 RESULT

• Galipeau J, Sensebe L. Mesenchymal Stromal Cells: Clinical Challenges and Therapeutic Opportunities. Cell Stem Cell. 2018 Jun 1;22(6):824-833. doi: 10.1016/j.stem.2018.05.004.

  PMID: 29859173 RESULT

• Hashemian SR, Aliannejad R, Zarrabi M, Soleimani M, Vosough M, Hosseini SE, Hossieni H, Keshel SH, Naderpour Z, Hajizadeh-Saffar E, Shajareh E, Jamaati H, Soufi-Zomorrod M, Khavandgar N, Alemi H, Karimi A, Pak N, Rouzbahani NH, Nouri M, Sorouri M, Kashani L, Madani H, Aghdami N, Vasei M, Baharvand H. Mesenchymal stem cells derived from perinatal tissues for treatment of critically ill COVID-19-induced ARDS patients: a case series. Stem Cell Res Ther. 2021 Jan 29;12(1):91. doi: 10.1186/s13287-021-02165-4.

  PMID: 33514427 RESULT

• Zanirati G, Provenzi L, Libermann LL, Bizotto SC, Ghilardi IM, Marinowic DR, Shetty AK, Da Costa JC. Stem cell-based therapy for COVID-19 and ARDS: a systematic review. NPJ Regen Med. 2021 Nov 8;6(1):73. doi: 10.1038/s41536-021-00181-9.

  PMID: 34750382 RESULT

• Wang C, Horby PW, Hayden FG, Gao GF. A novel coronavirus outbreak of global health concern. Lancet. 2020 Feb 15;395(10223):470-473. doi: 10.1016/S0140-6736(20)30185-9. Epub 2020 Jan 24. No abstract available.

  PMID: 31986257 RESULT

• Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.

  PMID: 32085846 RESULT

• Wang Y, Chen X, Cao W, Shi Y. Plasticity of mesenchymal stem cells in immunomodulation: pathological and therapeutic implications. Nat Immunol. 2014 Nov;15(11):1009-16. doi: 10.1038/ni.3002.

  PMID: 25329189 RESULT

• Leng Z, Zhu R, Hou W, Feng Y, Yang Y, Han Q, Shan G, Meng F, Du D, Wang S, Fan J, Wang W, Deng L, Shi H, Li H, Hu Z, Zhang F, Gao J, Liu H, Li X, Zhao Y, Yin K, He X, Gao Z, Wang Y, Yang B, Jin R, Stambler I, Lim LW, Su H, Moskalev A, Cano A, Chakrabarti S, Min KJ, Ellison-Hughes G, Caruso C, Jin K, Zhao RC. Transplantation of ACE2- Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia. Aging Dis. 2020 Mar 9;11(2):216-228. doi: 10.14336/AD.2020.0228. eCollection 2020 Apr.

  PMID: 32257537 RESULT

• Shu L, Niu C, Li R, Huang T, Wang Y, Huang M, Ji N, Zheng Y, Chen X, Shi L, Wu M, Deng K, Wei J, Wang X, Cao Y, Yan J, Feng G. Treatment of severe COVID-19 with human umbilical cord mesenchymal stem cells. Stem Cell Res Ther. 2020 Aug 18;11(1):361. doi: 10.1186/s13287-020-01875-5.

  PMID: 32811531 RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Xifeng Jiang, Doctor

  The First Hospital of Hebei Medical University

  STUDY CHAIR

• Gang Liu, Master

  The First Hospital of Hebei Medical University

  STUDY DIRECTOR

• Wuzhuang Sun, Master

  The First Hospital of Hebei Medical University

  STUDY DIRECTOR

• Baoyong Yan, Master

  The First Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

• Mingqi Zheng, Master

  The First Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

• Ding Yu, Master

  The First Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

• Le Wang, Master

  The First Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

• Yajie Wang, Master

  The First Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

• Quanhai Li, Master

  The First Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

• Xianyun Wang, Doctor

  The First Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

• Jiawei Yang, Postgraduate

  The First Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

• Tianshuo Li, Postgraduate

  The First Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianyun Wang, Doctor

CONTACT

031187156290; wangxianyun_mbb@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Cell Therapy Laboratory

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 23, 2023
• Study Start: January 28, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)