Ongoing stem cell based clinical trials in COVID-19
| Study title | Intervention | Study size | Description | Status | Country | Reference |
|---|---|---|---|---|---|---|
| Treatment of COVID-19 patients using Wharton’s Jelly-Mesenchymal Stem Cells | WJ-MSCs | 5 | Dose: 3 IV doses of 1×10e6/kg | Phase 1 | Jordan | 55 |
| Time: 3 days apart | ||||||
| Safety and Efficacy study of Allogenic Human Dental Pulp Mesenchymal Stem Cells to Treat Severe COVID-19 Patients | Allogenic Human Dental Pulp MSCs | 20 | Dose: IV of 3.0x10e7 human dental pulp stem cell solution (30 ml) on day 1, day 4 and day 7 | Phase 2 | China | 56 |
| Placebo: Intravenous Saline | IV of 3 ml of 0.9% saline at the same interval | |||||
| NestCell Mesenchymal Stem Cells to Treat Patients with Severe COVID-19 Pneumonia | NestCell | 66 | Dose: 2×107 cells (20 million cells) | Phase 1 | Brazil | 57 |
| Time: days 1, 3 and 5 in addition to standard care. | ||||||
| On day 7, cells will only be administered if necessary | ||||||
| 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 | HB-adMSCs | 100 | 3 groups of patients, will receive five IVs at 200, 100 and 50 million cells/dose | Phase 2 | USA | 58 |
| Infusions will occur at week 0, 2, 6, 10 and 14. Placebo is saline | ||||||
| Clinical Trial to Assess the Safety and Efficacy of Intravenous Administration of Allogeneic Adult Mesenchymal Stem Cells of Expanded Adipose Tissue in Patients With Severe Pneumonia Due to COVID-19 | Allogenic expanded adMSCs | 26 | Two doses of 80 million adipose-tissue derived mesenchymal stem cells | Phase 2 | Spain | 59 |
| 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 | HB-adMSCs | 56 | Dose: five IV infusions | Phase 2 | USA | 60 |
| Time: follow-up inflammatory data will be obtained at 6, 14, 26 weeks; and PHQ-9 Questionnaires at weeks 2, 6, 10, 14, 18, 22, 26 | ||||||
| Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem cells | Dental pulp MSCs | 24 | Dose: 1.0×106 cells/kg | Early Phase 1 | China | 51 |
| The injection of dental mesenchymal stem cells will be increased on day 1, 3 and 7 | ||||||
| Mesenchymal Stem Cell Treatment for Pneumonia Patients Infected With COVID-19 | MSCs | 20 | China | 61 | ||
| Treatment With Mesenchymal Stem Cells for Severe Corona Virus Disease 2019 (COVID-19) | MSCs | 90 | 3 times of MSCs (3.0*10E7 MSCs intravenously at Day 0, Day 3, Day 6) | Phase 1 | China | 62 |
| Saline containing 1% Human serum albumin (solution of MSC) | ||||||
| Bone Marrow-Derived Mesenchymal Stem Cell Treatment for Severe Patients With Coronavirus Disease 2019 (COVID-19) | BM-MSCs | 20 | Participants will receive conventional treatment plus BM-MSCs (1*10E6/kg body weight intravenously at Day 1) | Phase 2 | China | 63 |
| Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Severe COVID-19 | UC-MSCs | 48 | 4 times of UC-MSCs (0.5*10E6 UC-MSCs/kg body weight intravenously at Day 1, Day 3, Day 5, Day 7) | Not yet recrui-ting | China | 64 |
| Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Pneumonia of Coronavirus Disease 2019 | Drug: Oseltamivir and hormones MSCs | 60 | Umbilical cord mesenchymal stem cells were given at 106/Kg body weight/time, once every 4 days for a total of 4 times Peripheral intravenous infusion was given within 3 days of first admission | Early Phase 1 | China | 53 |
| Clinical Research of Human Mesenchymal Stem Cells in the Treatment of COVID-19 Pneumonia | UC-MSCs | 30 | 1*10E6 UC-MSCs/kg suspended in 100 ml saline | Phase 2 | China | 65 |
| Mesenchymal Stem Cell Therapy for SARS-CoV-2-related Acute Respiratory Distress Syndrome | Cell therapy | 60 | Protocol 1 (n=20). Two doses of MSCs 100×10e6 (± 10%) at Day 0 and Day 2 plus Conventional treatment | Phase 3 | Iran | 66 |
| Protocol 2: Two doses of MSCs 100×10e6 (± 10%)at Day 0 and Day 2, intravenously plus two doses of EVs at Day 4 and Day 6 plus conventional treatment | ||||||
| Role of Immune and Inflammatory Response in Recipients of Allogeneic Haematopoietic Stem Cell Transplantation (SCT) Affected by Severe COVID19 | No intervention | 40 | Comparison of biomarkers | Active, not re-cruiting | United King-dom | 67 |
| Use of UC-MSCs for COVID-19 Patients | UC-MSCs | 24 | UC-MSC will be administered at 100×106 cells/infusion administered intravenously in addition to the standard of care treatment | Phase 2 | USA | 68 |
| Stem Cell Educator Therapy Treat the Viral Inflammation in COVID-19 | Stem Cell Educator-Treated Mononuclear Cells Apheresis | 20 | SCE therapy circulates a patient’s blood through a blood cell separator, briefly cocultures the patient’s immune cells with adherent CB-SC in vitro, and returns the autologous immune cells to the patient’s circulation | Phase 2 | USA | 69 |
| Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19 | Drug: HB-and MSC | 110 | Dose: 4 IV of HB-adMSCs at 100 million cells/dose + hydroxychloroquine and azithromycin | Phase 2 | USA | 54 |
| Drug: Placebo | HB-adMSC infusions will occur at day 0, 3, 7, and 10 | |||||
| Drug: HC | Placebo: similar intervals without the HB-adMSCs | |||||
| Drug: AZ | ||||||
| Therapy for Pneumonia Patients Infected by 2019 Novel Coronavirus | Biological: UC-MSCs | N.A | 0.5*10E6 UC-MSCs/kg body weight suspended in 100 ml saline containing 1% human albumin intravenously at Day 1, Day 3, Day 5, Day 7 | With-drawn | China | 70 |
| Battle Against COVID-19 Using Mesenchymal Stromal Cells | Allogeneic and expanded adipose tissue-derived MSCs | 100 | Two serial doses of 1.5 million adipose-tissue derived mesenchymal stem cells/kg | Phase 2 | Madrid | 71 |
| Safety and Efficacy of CAStem for Severe COVID-19 Associated With/Without ARDS | CAStem | 9 | A dose-escalation with 3 cohorts with 3 patients/cohort who receive doses of 3, 5 or 10 million cells/kg | Phase 2 | China | 72 |
| ASC Therapy for Patients With Severe Respiratory COVID-19 | Stem Cell Product | 40 | 100 million allogeneic adipose-derived mesenchymal stromal cells diluted in 100 ml saline | Phase 2 | Denmark | 73 |
| Mesenchymal Stem Cells (MSCs) in Inflammation-Resolution Programs of Coronavirus Disease 2019 (COVID-19) Induced Acute Respiratory Distress Syndrome (ARDS) | MSC | 40 | Infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells | Phase 2 | Germany | 74 |
| Umbilical Cord(UC)-Derived Mesenchymal Stem Cells(MSCs) Treatment for the 2019-novel Coronavirus (nCOV) Pneumonia | UC-MSCs | 10 | UC-MSCs infusion intravenously on day 1, day 3, day 5, and day 7 | Phase 2 | China | 75 |
| A Pilot Clinical Study on Inhalation of Mesenchymal Stem Cells Exosomes Treating Severe Novel Coronavirus Pneumonia | MSCs-derived exosomes | 30 | 5 times aerosol inhalation of MSCs-derived exosomes (2.0*10E8 nano vesicles/3 ml at Day 1, Day 2, Day 3, Day 4, Day 5) | Phase 1 | China | 50 |
| MultiStem Administration for COVID-19 Induced ARDS (MACoVIA) | MultiStem | 400 | IV infusion of MultiStem | Phase 3 | USA | 76 |
| Cell Therapy Using Umbilical Cord-derived Mesenchymal Stromal Cells in SARS-CoV-2-related ARDS | UC Wharton’s jelly-derived human | 60 | Dose: 1 million/kg through an intravenous route | Phase 2 | France | 48 |
| Placebo: NaCl 0.9% | ||||||
| Treatment of Severe COVID-19 Pneumonia With Allogeneic Mesenchymal Stromal Cells (COVID_MSV) | Mesenchymal Stromal Cells | 24 | IV injection of 1 million MSV cells/Kg diluted in 100 ml saline | Phase 2 | Spain | 77 |
| Mesenchymal Stromal Cells for the Treatment of SARS-CoV-2 Induced Acute Respiratory Failure (COVID-19 Disease) | Mesenchymal Stromal Cells | 30 | Dose:1 × 108 MSCs through IV | Early Phase 1 | USA | 78 |
| Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration (REALIST) (COVID-19) | Remestemcel-L | 300 | Administered twice during the first week, with the second infusion at 4 days following the first injection (± 1 day) | Phase 3 | USA | 79 |
| Treatment of Covid-19 Associated Pneumonia With Allogenic Pooled Olfactory Mucosa-derived Mesenchymal Stem Cells | Allogenic pooled olfactory mucosa-derived MSCs | 40 | IV injection | Phase 2 | Minsk | 52 |
| Autologous Adipose-derived Stem Cells (AdMSCs) for COVID-19 | Autologous adMSCs | 200 | 3 doses of 200 million cells through IV every 3 days | Phase 2 | USA | 49 |
| Mesenchymal Stem Cell Infusion for COVID-19 Infection | MSCs | 20 | Dose: 2 × 106 cells/kg, administered on day 1, 7 in addition to supportive care | Phase 2 | Pakistan | 80 |
| Safety and Efficacy of Mesenchymal Stem Cells in the Management of Severe COVID-19 Pneumonia (CELMA) | UC-MSCs | 30 | Dose: 1*106 cells/Kg | Phase 2 | USA | 81 |
| Mesenchymal Stem Cell for Acute Respiratory Distress Syndrome Due for COVID-19 (COVID-19) | MSC | 10 | Dose: 1 million/Kg | Phase 2 | Mexico | 82 |
| NestaCellⓇ Mesenchymal Stem Cell to Treat Patients With Severe COVID-19 Pneumonia (HOPE) | NestaCellⓇ | 90 | Dose : 2×107 cells on days 1, 3, 5 and 7 | Phase 2 | Brazil | 83 |
| Treatment With Human Umbilical Cord-derived Mesenchymal Stem Cells for Severe Corona Virus Disease 2019 (COVID-19) | UC-MSCs | 100 | Dose: 3 of 4.0*10E7 cells at Day 0, Day 3, Day 6 | Phase 2 | China | 84 |
| Efficacy of Intravenous Infusions of Stem Cells in the Treatment of COVID-19 Patients | MSCs | 20 | IV injection of Cultured stem cells at days 1, 3 and 5 | Phase 2 | Turkey | 85 |
| Clinical Use of Stem Cells for the Treatment of Covid-19 | MSCs | 30 | Dose: 3 million cells/kg on days 0, 3 and 6 | Phase 2 | Turkey | 86 |
| Safety and Efficacy of Intravenous Wharton’s Jelly Derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Due to COVID 19 | WJ-MSCs | 40 | 2 doses | Phase 2 | Colombia | 87 |
| MSCs in COVID-19 ARDS | Remestemcel-L | 300 | Twice in the first week with a gap of 4 days between the injections | Phase 3 | USA | 88 |
| Efficacy and Safety Evaluation of Mesenchymal Stem Cells for the Treatment of Patients With Respiratory Distress Due to COVID-19 (COVIDMES) | WJ-MSCs | 30 | Administration along with standard care | Phase 2 | Spain | 89 |
| Cellular Immuno-Therapy for COVID-19 Acute Respiratory Distress Syndrome - Vanguard (CIRCA-19) | MSCs | 9 | IV administration | Phase 1 | Canada | 90 |
| ACT-20 in Patients With Severe COVID-19 Pneumonia | Allogenic UC-MSCs | 70 | 1 million cells/kg body weight in 100 ml in conditioned media | Phase 2 | 91 | |
| Study of the Safety of Therapeutic Tx With Immunomodulatory MSC in Adults With COVID-19 Infection Requiring Mechanical Ventilation | Allogenic BM-MSC | 45 | IV administration | Phase 1 | USA | 92 |
| Double-Blind, Multicenter, Study to Evaluate the Efficacy of PLX PAD for the Treatment of COVID-19 | MSCs | 140 | 15 IM injections (1 ml each). Twice with an interval of 1 week | Phase 2 | USA | 93 |
| A Study of Cell Therapy in COVID-19 Subjects With Acute Kidney Injury Who Are Receiving Renal Replacement Therapy | MSCs and a plasmapheresis device | 24 | Administered through integration into a Continuous Renal Replacement Therapy circuit | Phase 2 | 94 |
WJ: Wharton’s Jelly; MSC: Mesenchymal stem cells; adMSCs: adipose derived MSCs; UC: Umbilical cord; IV: Intravenous; BM: Bone marrow; HC: hydroxychloroquine; AZ: azithromycin.