Trial ChiCTR2000031494
Publication Shu L, Stem Cell Res Ther (2020) (published paper)
Dates: 12/02/2020 to 25/03/2020
Funding: Public/non profit (National Natural Science Foundation of China; Key Research and Development Project of Jiangsu Province)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / China
Follow-up duration (days): 28
Inclusion criteria
  • Report:
    In general, patients with severe COVID-19 whose clinical symptoms were not significantly alleviated under standard treatment for 7 to 10 days were recommended for participation in this pilot study.

    Registry:
    (1) Aged 18 to 90 years old, male or female

  • (2) Patients with a definite diagnosis of new type of coronavirus pneumonia

  • (3) Expected survival time > 10 days

  • (4) Serology: HIV antibody negative
  • hepatitis B surface antigen, e antigen negative
  • hepatitis C antibody negative
  • female patients with negative pregnancy test
  • ALT, AST <=2.5 ULN
  • for patients with liver metastases, ALT, AST <=5 ULN
  • ALP <=2.5 ULN
  • serum urea nitrogen and creatinine <=1.5 ULN
  • serum total bilirubin <1.5 times the upper limit of normal

  • (6) Patients or their legal representatives can understand and voluntarily sign informed consent.
Exclusion criteria
  • Report:
    Exclusion criteria included the following: any kind of cancer, severe liver disease, known allergy or hypersensitivity to hUC-MSCs, and other conditions that the clinician deemed inappropriate for participation.

    Registry:
    1. With any autoimmune disease

  • 2. with malignant tumors

  • 3. Participated in other clinical studies within three months before entering the group

  • 4. Severe allergic history, allergic to T cell therapy products or other biological agents

  • 5. Pregnant, planning to become pregnant or lactating women

  • 6. Patients with severe systemic diseases who are not suitable for entering the study, including but not limited to severe liver dysfunction, severe coagulation disorders, severe mental diseases, etc.

  • 7. Previously received other stem cell therapy, had received CIK cell therapy within two months

  • 8. Researchers believe that other conditions should not be included in this trial
Interventions
Treatment
hUC-MSC
2 x 10^6 cells/kg IV in 100 mL of normal saline once off.
Control
Standard care

Participants
Randomized
participants :
hUC-MSC=12
Standard care=29
Characteristics of participants
N= 41
Mean age : NR
24 males
Severity : Mild: n=3 / Moderate: n=28 / Severe: n=10 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
Chest Imaging; Lung Function; ADL
In the report
Incidence of progression from severe to critical illness and the time to a clinical improvement of two points on a seven-category ordinal scale
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment "In addition to the published article, the study registry was used in data extraction and risk of bias assessment. This is a report on a single centre pilot study. The target sample size of 18 specified in the registry was not achieved for the intervention arm. There is no change from the trial registration in the intervention and control treatments. The inclusion and exclusion criteria in the registry and report do not match. The primary outcome and all secondary outcomes from the report are not specified in the trial registry."