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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