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Table 1 Overview of planned or ongoing studies of cell therapy for the treatment of COVID-19

From: The role of mesenchymal stromal cells in immune modulation of COVID-19: focus on cytokine storm

NO Title and sponsor Trial ID Location Design Primary outcome Recruitment status Phase
1. A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Allogeneic Mesenchymal Stem Cell Therapy (HB-ADMSCs) to Provide Protection Against COVID-19
Sponsor:
Hope Biosciences
NCT04348435 Texas, USA Randomized, placebo-controlled, double-blinded, clinical trial to assess effectiveness of HB-allogeneic adipose-derived mesenchymal stem cells to supply immune support against coronavirus illness.N:100. • Incidence of hospitalization for COVID-19
• Incidence of symptoms associated with COVID-19
Enrolling by invitation
April 16, 2020
Phase 2
2. A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy (HB-ADMSCs) to Provide Protection Against COVID-19
Sponsor:
Hope Biosciences
NCT04349631 Texas, USA Open label, single-center, and clinical trial to assess effectiveness of HB-ADMSCs to produce immune support against coronavirus illness.N:56. • Incidence of hospitalization for COVID-19
• Incidence of symptoms associated with COVID-19
Enrolling by invitation
April 16, 2020
Phase 2
3. Natural Killer Cell (CYNK-001) Infusions in Adults With COVID-19 (CYNK-001-COVID-19) (CYNK001COVID)
Sponsor:
Cellularity Incorporated
NCT04365101 ? Open label, randomized, phase I can assess the safety and effectivity of multiple doses of CYNK-001 (days 1, 4, and 7) in 14 patients.
Phase II can utilize a randomized, open-label design; multiple doses of CYNK-001 are compared to the control group. Up to 72 patients are enclosed within the phase II clinical trial portion of the study with a 1:1 randomization ratio.
• Frequency and severity of adverse events (AE)
• Time to clearance of SARS-CoV-2
Not yet recruiting
April 28, 2020
Phase 1
Phase 2
4. Treatment of Severe COVID-19 Pneumonia With Allogeneic Mesenchymal Stromal Cells (COVID_MSV) (COVID_MSV)
Sponsor:
Red de Terapia Celular
NCT04361942 Valladolid, Spain Double-blind, placebo-controlled, N:24, mesenchymal stromal cells, evaluate safety and efficacy of mesenchymal stromal cells from allogenic tissue for treatment of acute respiratory failure in patients with COVID-19. • Proportion of patients who have achieved withdrawal of invasive mechanical ventilation
• Rate of mortality
Recruiting
April 24, 2020
Phase 2
5. Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Pneumonia of Coronavirus Disease 2019
Sponsor:
Fuzhou General Hospital
NCT04371601 Fuzhou, Fujian, China Open label, randomized, N: 60, control group: standard symptomatic treatments like antiviral (Oseltamivir), hormones, oxygen therapy, mechanical ventilation, and different accessory therapies; Experimental group: On the basis of the above-named standard symptomatic treatment and supportive medical aid, UC-MSCs were given at 106 / kg weight / time, once each 4 days for four times. iv infusion was given at intervals 3 days of 1st admission. • Changes of oxygenation index (PaO2/FiO2),blood gas test Active, not recruiting
May 1, 2020
Early Phase 1
6. Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19
Sponsor:
KK Women’s and Children’s Hospital
NCT04351659 Singapore Observational, novel adoptive cellular therapy with SARS-CoV-2-specific T cells in patients with severe COVID-19,N:8 • Success rate in production of SARS-CoV-2 specific T cells from convalescent donor Recruiting
April 17, 2020
….
7. Bone Marrow-Derived Mesenchymal Stem Cell Treatment for Severe Patients With Coronavirus Disease 2019 (COVID-19)
Sponsor:
Guangzhou Institute of Respiratory Disease
NCT04346368 Guangzhou, Guangdong, China Randomized controlled trial, parallel, N = 20, BM-MSCs in severe patients with coronavirus disease 19. • Changes of oxygenation index (PaO2/FiO2)
• Side effects in the BM-MSCs treatment group
Not yet recruiting
April 15, 2020
Phase 1
Phase 2
8. Mesenchymal Stromal Cells for the Treatment of SARS-CoV-2 Induced Acute Respiratory Failure (COVID-19 Disease)
Sponsor:
Baylor College of Medicine
NCT04345601 Houston, Texas, USA Pilot study, N = 30,, BM-MSCs for the treatment of SARS-CoV-2 induced acute respiratory failure • Incidence of unexpected adverse events
• Improved oxygen saturations ≥93%
Not yet recruiting
April 20, 2020
Early Phase 1
9. Phase I / II Clinical Study of Immunotherapy Based on Adoptive Cell Transfer as a Therapeutic Alternative for Patients With COVID-19 in Colombia
Sponsor:
Universidad Nacional de Colombia
NCT04344548 Bogota, Cundinamarca, Colombia Open label, single group assignment, N = 10, allogeneic NK transfer • Adverse effects and safety Not yet recruiting
April 14, 2020
Phase 1
Phase 2
10. NK Cells Treatment for COVID-19
Sponsor:
Xinxiang medical university
NCT04280224 Xinxiang, Henan, China Open label, randomized, N = 30, natural killer cells treatment in pneumonia patients infected with 2019 novel coronavirus • Improvement of clinical symptoms including duration of fever
• Improvement of clinical symptoms including respiratory frequency
Recruiting
February 21, 2020
Phase 1
11. Cell Therapy Using Umbilical Cord-derived Mesenchymal Stromal Cells in SARS-CoV-2-related ARDS (STROMA-CoV2)
Sponsors:
Assistance Publique - Hôpitaux de Paris
NCT04333368 Paris, France Triple, randomized
N = 60 patients, 20 patients will be cell-treated whereas the remaining 40 patients will be injected with a placebo in addition to the standard of care.
• Respiratory efficacy evaluated by the increase in PaO2/FiO2 ratio from baseline to day 7 in the experimental group compared with the placebo group [time frame: from baseline to day 7] Not yet recruiting
April 3, 2020
Phase 1
Phase 2
12. ASC Therapy for Patients With Severe Respiratory COVID-19 (ASC COVID-19)
Sponsors:
Rigshospitalet, Denmark
NCT04341610 Copenhagen, Denmark Double-blind placebo-controlled, randomized, N = 40 participants, allogeneic adipose-derived, mesenchymal stem cells or placebo will be injected to COVID-19 patients having severe pulmonary dysfunction. • Changes in clinical critical treatment index [time frame: day 7 from randomization] Not yet recruiting
April 10, 2020
Phase 1
Phase 2
13. Safety and Efficacy of CAStem for Severe COVID-19 Associated With/Without ARDS
Sponsors:
Chinese Academy of Sciences
NCT04331613 Beijing, China Open label, single group, CAStem will be injected to severe COVID-19 associated with or without acute respiratory distress syndrome (ARDS), CAStem will be administered iv route. • Adverse reaction (AE) and severe adverse reaction (SAE)
• Frequency of adverse reaction (AE) and severe adverse reaction (SAE) within 28 days after treatment
• Changes of lung imaging examinations
• Evaluation by chest CT
Recruiting
April 3, 2020
Phase 1
Phase 2
14. A Phase I/II Study of Universal Off-the-shelf NKG2D-ACE2 CAR-NK Cells for Therapy of COVID-19
Sponsors:
Chongqing Public Health Medical Center
NCT04324996 Chongqing, China Interventional, quadruple,randomized, a phase I/II study of universal off-the-shelf NKG2D-ACE2 CAR-NK cells secreting IL15 super agonist and GM-CSF-neutralizing scFv for treatment of COVID-19 • Clinical response [time frame: up to 28 days]
• Side effects in the treatment group [time frame: up to 28 days]
Recruiting,
March 27, 2020
Phase 1
Phase 2
15. Clinical Research of Human Mesenchymal Stem Cells in the Treatment of COVID-19 Pneumonia
Sponsors:
Puren Hospital Affiliated to Wuhan University of Science and Technology
NCT04339660 Wuhan, Hubei, China Triple, randomized, N = 30
Human mesenchymal stem cells in the treatment of COVID-19 pneumonia
• The immune function (TNFα, IL-1β, IL-6, TGF-β, IL-8, PCT, CRP)
• Blood oxygen saturation
Recruiting
April 9, 2020
Phase 1
Phase 2
16. Stem Cell Educator Therapy Treat the Viral Inflammation Caused by Severe Acute Respiratory Syndrome Coronavirus 2
Sponsor:
Tianhe Stem Cell Biotechnologies Inc.
NCT04299152 ? Randomized = 20
Two-arm, partially masked, single center clinical study to assess the safety, feasibility, and efficacy of SCE therapy for the treatment of patients with SARS-CoV-2.
• Determine the number of COVID-19 patients who were unable to complete SCE therapy Not yet recruiting
March 6, 2020
Phase 2
17. Treatment With Mesenchymal Stem Cells for Severe Corona Virus Disease 2019(COVID-19)
Sponsors:
Beijing 302 Hospital
NCT04288102 Hubei, China Prospective, double-blind, multicenter, randomized trial
N = 60 severe COVID-19 patients randomized 2:1 to 3 iv doses of mesenchymal stem cells (MSCs) or placebo (saline).
• Improvement time of clinical critical treatment index within 28 days
• Side effects in the MSCs treatment group
Recruiting;
August 31, 2020/December 31, 2020
Phase 2
18. Therapy for Pneumonia Patients infected by 2019 Novel Coronavirus
Sponsors:
Puren Hospital Affiliated to Wuhan University of Science and Technology
NCT04293692 China, Hubei Triple-blinded RCT.
N = 48 with moderate to severe COVID-19 randomized to UC-MSCs or placebo
• Size of lesion area by chest imaging
• Blood oxygen saturation
Recruiting;
May 12,020/Feb 1, 2021
Not Applicable
19. Clinical Trial for Human Mesenchymal Stem Cells in the Treatment of Severe Novel Coronavirus Pneumonia (COVID-19)
Sponsor:
Chinese PLA General Hospital
ChiCTR2000030138 Hainan, China Randomized, double-blind, placebo-controlled trial
N = 60 randomized to human umbilical cord mesenchymal stem cells (UC-MSC), or placebo in COVID-19.
• Clinical index Not yet recruiting;
From 2020-02-24 to 2020-05-31
Phase 2
20. Mesenchymal Stem Cell Treatment for Pneumonia Patients Infected With 2019 Novel Coronavirus
Sponsors:
Beijing 302 Hospital
NCT04252118 China Open-label, non-randomized intervention study
N = 20 patients with COVID-19
Treatment: N = 10 treated with MSN
N = 10 treated with conventional treatment.
• Size of lesion area by chest radiograph or CT (time frame day 28)
• Side effects day (time frame day 180)
Recruiting;
Dec 2020/December, 2021
Phase 1
21. A Pilot Clinical Study on Inhalation of Mesenchymal Stem Cells Exosomes Treating Severe Novel Coronavirus Pneumonia
Sponsors:
Ruijin Hospital
NCT04276987 China Open-label pilot study
N = 30 with severe COVID-19,
Single group assignment
• Adverse reactions
• Time to clinical improvement (28 days)
Not yet recruiting;
Estimated study completion: July 31, 2020
Phase 1
22. Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Novel Coronavirus Severe Pneumonia
Sponsor:
Wuhan Union Hospital, China
NCT04273646 China, Hubei Open-label, randomized study
N = 48 with severe COVID-19; Randomized to stem cell therapy or placebo
• Pneumonia severity index
• Oxygenation index (PaO2/FiO2)
Not yet recruiting;
June 302,020/Feb 15, 2022
Not Applicable
23. Safety and efficacy of umbilical cord blood mononuclear cells conditioned medium in the treatment of severe and critically novel coronavirus pneumonia (COVID-19): a randomized controlled trial
Sponsor:
Xiangyang 1st People’s Hospital
ChiCTR2000029569 China, Hubei Open label
N = 30 with severe and critical COVID-19. Randomized to stem cell or conventional treatment.
• PSI Not recruiting
From 2020-02-05 to 2021-04-30
0
24. Umbilical Cord(UC)-Derived Mesenchymal Stem Cells(MSCs) Treatment for the 2019-novel Coronavirus (nCOV) Pneumonia
Sponsor:
ZhiYong Peng
NCT04269525 China, Hubei Open label
N = 10, serious or critical COVID-19
• Oxygenation index day 14
• Partial arterial oxygen pressure (PaO2) / oxygen concentration (FiO2)
Recruiting;
April 30, 2020/Sept 30, 2020
Phase 2
25. Clinical Study for Human Menstrual Blood-Derived Stem Cells in the Treatment of Acute Novel Coronavirus Pneumonia (COVID-19)
Sponsor:
The First Affiliated Hospital, College of Medicine, Zhejiang University
ChiCTR2000029606 Zhejiang, China Open-label, 5-arm study.
Critically ill patients treated with stem cells, conventional treatment, artificial liver therapy, artificial liver therapy + stem cells, or conventional treatment
• Mortality in patients Recruiting;
From 2020-01-15 to 2022-12-31
0
26. Canceled by the investigator Clinical Study for Umbilical Cord Blood Mononuclear Cells in the Treatment of Acute Novel Coronavirus Pneumonia (COVID-19)
Sponsor:
Guangzhou reborn health management consultation co., LTD
ChiCTR2000029812 Guangdong, China Open label,
N = 60 patients with COVID-19 randomized to umbilical cord blood mononuclear cells or conventional treatment
• Time to disease recovery Not recruiting;
From 2020-02-20 to 2021-02-20
0
27. Clinical Study of Cord Blood NK Cells Combined with Cord Blood Mesenchymal Stem Cells in the Treatment of Acute Novel Coronavirus Pneumonia (COVID-19)
Sponsor:
Guangzhou Reborn Health Management Consultation Co., LTD
ChiCTR2000029817 Guangdong, china Open label,
N = 60 patients with COVID-19 randomized to high-dose NK cells, and mesenchymal stem cells, conventional dose NK cells and mesenchymal stem cells, or preventive dose NK cells and mesenchymal stem cells.
• Time to disease recovery Not recruiting;
From 2020-02-20 to 2021-02-20
0
28. Canceled by the investigator Clinical Study for Umbilical Cord Blood Plasma in the Treatment of Acute Novel Coronavirus Pneumonia (COVID-19)
Sponsor:
Guangzhou reborn health management consultation co., LTD
ChiCTR2000029818 Guangdong, china Open label,
N = 60 patients with COVID-19 randomized to high-dose NK cells, and mesenchymal stem cells, conventional dose NK cells and mesenchymal stem cells, or preventive dose NK cells and mesenchymal stem cells.
• Time to disease recovery Not recruiting;
From 2020-02-20 to 2021-02-20
0
29. Clinical trials of mesenchymal stem cells for the treatment of pneumonitis caused by novel coronavirus pneumonia (COVID-19)
Sponsor:
Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences
ChiCTR2000029990 Beijing, Hubei, Shanghai N = 120, severe COVID-19 randomized to MSCs or saline • Improved respiratory system function (blood oxygen saturation) recovery time Recruiting;
From 2020-01-30 to 2020-03-31
Phase 1–2
30. Umbilical cord Wharton’s Jelly derived mesenchymal stem cells in the treatment of severe novel coronavirus pneumonia (COVID-19)
Sponsor:
The Sixth Medical Center of PLA General Hospital
ChiCTR2000030088 Beijing, China Type of study not stated. Blinding not stated N = 40 with critical COVID-19. Treatment: stem cells (n = 20)
40 ml saline (n = 20)
• The nucleic acid of the novel coronavirus is negative
• CT scan of ground-glass shadow disappeared
Not yet recruiting;
From 2020-03-01 to 2021-12-31
0
31. Safety and effectiveness of human umbilical cord mesenchymal stem cells in the treatment of acute respiratory distress syndrome of severe novel coronavirus pneumonia (COVID-19)
Sponsor:
The First Affiliated Hospital of Nanchang University
ChiCTR2000030116 Jiangxi, China N = 16 with critical COVID-19; different stem cell doses • Time to leave ventilator on day 28 after receiving MSCs infusion Recruiting;
From 2020-02-01 to 2020-08-31
N/A
32. Canceled by the investigator Clinical study of mesenchymal stem cells in treating severe novel coronavirus pneumonia (COVID-19)
Sponsor:
The First Affiliated Hospital of Nanchang University
ChiCTR2000030224 Hubei, China Clinical study, open label
Severe or critical COVID-19 patients;
N = 32 stratified severity and randomized to stem cells or injection with saline
• Several primary endpoints—not specified Not yet recruiting;
From 2020-02-14 to 2020-05-31
N/A
33. Umbilical cord mesenchymal stem cells (hUC-MSCs) in the treatment of high risk novel coronavirus pneumonia (COVID-19) patients
Sponsor:
Nanjing Second Hospital
ChiCTR2000030300 Jiangsu, China A single-center, single-arm, prospective, open clinical study
N = 9. UC-MSCs will be injected to COVID-19 patients.
• Time to disease recovery;
• Exacerbation (transfer to RICU) time
Recruiting;
From 2020-02-19 to 2021-02-20
Phase 1
34. Stem Cell Educator Therapy Treat the Viral Inflammation Caused by Severe Acute Respiratory Syndrome Coronavirus 2
Sponsor:
Tianhe Stem Cell Biotechnologies Inc.
NCT04299152 ? This is a prospective, two-arm, partially masked, single-center clinical study.
N = 20 patients with SARS-CoV-2 undergoing either stem cell therapy or conventional treatment
• Determine the number of COVID-19 patients who were unable to complete SCE therapy
• The feasibility will be evaluated by the number of COVID-19 patients who were unable to complete SCE therapy
Not yet recruiting;
Nov 2020
Phase 2
35. Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells
Sponsor:
CAR-T (Shanghai) Biotechnology Co., Ltd.
NCT04302519 ? Single-arm study
N = 24. Patients with severe COVID-19 assigned to stem cell therapy.
• Disappear time of ground-glass shadow in the lungs [time frame: 14 days] Not yet recruiting, July 2021 phase 1
36. Treatment of COVID-19 Patients Using Wharton’s Jelly-Mesenchymal Stem Cells
Sponsor:
Stem Cells Arabia
NCT04313322 Jordan Single-arm study
N = 5 with COVID-19
• Improvement of clinical symptoms;
• Adverse events;
• Viral RNA
Recruiting.
Sept 2020
Phase 1
37. NestCell® Mesenchymal Stem Cell to Treat Patients With Severe COVID-19 Pneumonia (HOPE)
Sponsor:
Azidus Brazil
NCT04315987 Not stated N = 24 patients • Disappear time of ground-glass shadow in the lungs Not yet recruiting.
June 2020
Phase 1–2
38. Study the effect of intravenous injection of dental pulp mesenchymal stem cells in treatment of patients with COVID-19 pneumonia
Sponsor:
Kerman University of Medical Sciences
IRCT20140911019125N6 Iran, Kerman Clinical trial without control group, community based, not blinded, non-randomized controlled study.
Dental pulp mesenchymal stem cells will be injected intravenously at one time.
• Pulmonary condition
• Expression of nucleic acid of virus
• Lymphocyte count
• Patients clinical signs
Recruiting,
2020-04-04,
Phase 2
39. Evaluation of the efficacy and safety of cord-derived mesenchymal stem cell transplantation in the treatment of COVID-19
Sponsor:
MOM research and innovation center
IRCT20140528017891N8 Iran, Tehran This study was a parallel randomized controlled clinical trial study design. The sample size of the study is 10 corona virus patients that will be assigned to intervention and control groups using simple randomization method. • Death
• Evaluation of Pneumonia Severity Index
• Evaluation of oxygen supply index
• C- Reactive protein
• Pro-calcitonin
• Lymphocyte count
• Counting of CD3 +, CD4 + and CD8 + T cells
• + CD4 + / CD8 ratio
• Improve pneumonia evaluated by CT scan
Recruitment complete, 2020-03-24 Phase 3
40. Mesenchymal stem cell utilization in reducing complications and enhancing pneumonia healing in patients infected with 2019-nCoV (phase I clinical trial)
Sponsor:
Bagheiatallah University of Medical Sciences
IRCT20200325046860N2 Iran, Tehran Experimental: mesenchymal stem cell (MSC) treatment group conventional treatment plus MSC participants will receive conventional treatment plus 3 times of MSCs (7.0 × 10E7 MSCs intravenously at day 0, day 3, day 6), 5 patients, clinical trial phase I No intervention: conventional control group without MSC therapy but conventional treatment should be received. • Respiratory function of patients Recruitment complete, 2020-04-01 Phase 1
41. A Comparison Study on Safety & Efficacy of Repeated Intravenous Infusion of Allogeneic Mesenchymal Stem Cell from Different Sources in ARDS Patients: A Randomized, Double Blind, Clinical Trial Phase II
Sponsor:
Bagheiatallah University of Medical Sciences
IRCT20080901001165N44 Iran, Tehran A uncontrolled, parallel, double-blind, randomized, clinical trial, phase II 4 groups, 3 patients in each group, totally 12 patients 4 cell interventional groups 12 months follow-up • Numbers of patients occurred any unexpected severe adverse events (including all-cause deaths) Recruiting,
2020-03-29
Phase 1–2
42. Mesenchymal Stem Cell Therapy for Acute Respiratory Distress Syndrome in Coronavirus Infection: A Phase 2–3 Clinical Trial
Sponsor:
Iranian academic center for education culture and research
IRCT20200217046526N2 Iran, Tehran A controlled randomized clinical trial phase 2–3 • Adverse events assessment
• Blood oxygen saturation
Recruiting,
2020-04-05
Phase 2–3
43. Cell therapy in patients with coronavirus19 using mesenchymal stem cells
Sponsor:
Barekat Pharmaceutical Group
IRCT20190717044241N2 Iran, Tehran One group with 10 uncontrolled patients, Phase I clinical trial • Clinical response
• partial arterial oxygen pressure (PaO2) & oxygen concentration (FiO2)
Recruiting, 2020-04-20 Phase 1