Table 1.
Clinical trials registered on ClinicalTrials.gov till 16 July 2020 utilizing Stem Cells for the treatment of COVID-19
| Study identifier | Stem cell source | Study phase; estimated enrollment (N) | Primary outcome measure(s) | Recruitment status |
|---|---|---|---|---|
| NCT04473170 | Autologous Non-hematopoietic peripheral blood stem cells |
Phase I/II; N = 146 |
Adverse reactions incidence (Time frame: Day 0–28); Rate of mortality within 28 days (Time frame: Day 0–28); Time to clinical improvement on a seven-category ordinal scale (Time frame: Day 0–28) | Completed |
| NCT04457609 | Umbilical cord derived mesenchymal stem cells |
Phase I; N = 40 |
Clinical improvement: Presence of dyspnea (Time frame: 15 days); Clinical improvement: presence of sputum (Time frame: 15 days); Clinical improvement: fever (Time frame: 15 days); Clinical improvement: ventilation status (Time frame: 15 days); Clinical improvement: blood pressure (Time frame: 15 days); Clinical improvement: heart rate (Time frame: 15 days); Clinical improvement: respiratory rate (Time frame: 15 days); Clinical improvement: oxygen saturation (Time frame: 15 days) | Recruiting |
| NCT04461925 | Mesenchymal stem cells from placenta and umbilical cord |
Phase I/II; N = 30 |
Changes of oxygenation index PaO2/FiO2, most conveniently the P/F ratio. (Time frame: up to 28 days); Changes in length of hospital stay (Time frame: up to 28 days); Changes in mortality rate (Time frame: up to 28 days) | Recruiting |
| NCT04467047 | Allogenic bone marrow mesenchymal stem cells |
Phase I; N = 10 |
Overall survival (Time frame: 60 days) | Not yet recruiting |
| NCT04466098 | Mesenchymal stromal cells (source not defined) |
Phase II; N = 30 |
Incidence of grade 3–5 infusional toxicities and predefined hemodynamic or respiratory adverse events related to the infusion of MSC (Time frame: Within 6 h of the start of the infusion) | Not yet recruiting |
| NCT04313322 | Wharton's Jelly mesenchymal stem cells |
Phase I; N = 5 |
Clinical outcome (Time frame: 3 weeks); CT Scan (Time frame: 3 weeks); RT-PCR results (Time frame: 3 weeks) | Recruiting |
| NCT04428801 | Autologous adipose-derived stem cells |
Phase II; N = 200 |
Tolerability and acute safety of AdMSC infusion by assessment of the total number of AEs/SAEs related and non-related with the medication (Time frame: 6 months); The overall proportion of subjects who develop any AEs/SAEs related and non-related with the AdMSC infusions as compared to the control group (Time frame: 6 months); COVID-19 incidence rates in both the study and control groups (Time frame: 6 months) | Not yet recruiting |
| NCT04444271 | Bone marrow-derived mesenchymal stem cells |
Phase II; N = 20 |
Overall survival (Time frame: 30 days post intervention) | Recruiting |
| NCT04416139 | Umbilical cord mesenchymal stem cells |
Phase II; N = 10 |
Functional respiratory changes: PaO2 / FiO2 ratio (Time frame: 3 weeks); Clinical cardiac changes: Heart rate per minute (Time frame: 3 weeks); clinical respiratory changes: respiratory rate per minute (Time frame: 3 weeks); Changes in body temperature (Time frame: 3 weeks) | Recruiting |
| NCT04336254 | Allogeneic human dental pulp stem cells |
Phase I/II; N = 20 |
Time to clinical improvement (Time frame: 1–28 days) | recruiting |
| NCT04429763 | Umbilical cord derived mesenchymal stem cells |
Phase II; N = 30 |
Clinical deterioration or death (Time frame: 4 weeks) | Not yet recruiting |
| NCT04456361 | Mesenchymal stem cells derived from wharton jelly of umbilical cords |
Early Phase I; N = 9 |
Oxygen saturation (Time frame: Baseline, and at days 2, 4 and 14 post-treatment) | Active, not recruiting |
| NCT04315987 | mesenchymal stem cells (source not defined) |
Phase II; N = 90 |
Change in clinical condition (Time frame: 10 days) | Not yet recruiting |
| NCT04366323 | Allogenic and expanded adipose tissue-derived mesenchymal stem cells |
Phase I/II; N = 26 |
Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse event rate (Time frame: 12 months); Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate (Time frame: 28 days) | Recruiting |
| NCT04348435 | Allogeneic adipose-derived mesenchymal stem cells |
Phase II; N = 100 |
Incidence of hospitalization for COVID-19 (Time frame: week 0 through week 26); Incidence of symptoms associated with COVID-19 (Time frame: week 0 through week 26) | Enrolling by invitation |
| NCT04349540 | Allogenic haematopoietic stem cells |
Not defined; N = 40 |
Comparison of inflammatory/immunological biomarkers < 72 h after development of oxygen requirement (Time frame: 72 h) | Active, not recruiting |
| NCT04252118 | Umbilical cord derived mesenchymal stem cells |
Phase I; N = 20 |
Size of lesion area by chest radiograph or CT (Time frame: At Baseline, Day 3, Day 6, Day 10, Day 14, Day 21, Day 28); Side effects in the MSC treatment group (Time frame: at baseline, Day 3, Day 6, Day 10, Day 14, Day 21, Day 28, Day 90 and Day 180) | Recruiting |
| NCT04382547 | Allogenic-pooled olfactory mucosa-derived mesenchymal stem cells |
Phase I/II; N = 40 |
Number of cured patients (Time frame: 3 weeks) | Enrolling by invitation |
| NCT04349631 | Autologous adipose-derived mesenchymal stem cells |
Phase II; N = 56 |
Incidence of hospitalization for COVID-19 (Time frame: Week 0 through week 26); Incidence of symptoms for COVID-19 (Time frame: week 0 through week 26) | Enrolling by invitation |
| NCT04273646 | Human umbilical cord mesenchymal stem cells |
Not Applicable; N = 48 |
Pneumonia severity index (Time frame: From baseline (0 W) to 12 weeks after treatment); Oxygenation index (PaO2/FiO2) (Time frame: From Baseline (0 W) to 12 weeks after treatment) | Not yet recruiting |
| NCT04346368 | Bone marrow-derived mesenchymal stem cells |
Phase I/II; N = 20 |
Changes of oxygenation index (PaO2/FiO2) (Time frame: At baseline, 6 h, Day 1, Day 3,Week 1, Week 2, Week 4, Month 6); Side effects in the BM-MSC treatment group (Time frame: Baseline through 6 months) | Not yet recruiting |
| NCT04288102 | Umbilical cord derived mesenchymal stem cells |
Phase II; N = 100 |
Change in lesion proportion (%) of full lung volume from baseline to day 28. (Time frame: Day 28) | Active, not recruiting |
| NCT04366063 | Mesenchymal stem cells (source not defined) |
Phase II/III; N = 60 |
Adverse events assessment (Time frame: From baseline to day 28); Blood oxygen saturation (Time frame: From baseline to day 14) | Recruiting |
| NCT04437823 | Umbilical cord derived mesenchymal stem cells |
Phase II; N = 20 |
Safety and efficacy assessment of infusion associated adverse events (Time frame: Day 01 to Day 30); Chest radiograph or Chest CT scan (Time frame: Day 01 to Day 30) | Recruiting |
| NCT04302519 | Dental pulp mesenchymal stem cells |
Early Phase I; N = 24 |
Disappearing time of ground-glass shadow in the lungs (Time frame: 14 days) | Not yet recruiting |
| NCT04447833 | Allogenic bone marrow derived mesenchymal stem cells |
Phase I; N = 9 |
The incidence of pre-specified treatment-related adverse events of interest (TRAEIs). (Time frame: From drug administration to day 10 post-infusion) | Recruiting |
| NCT04390152 | Wharton's jelly derived mesenchymal stem cells |
Phase I/II; N = 40 |
Intergroup mortality difference with treatment (Time frame: 28 days) | Not yet recruiting |
| NCT04339660 | Human umbilical cord-derived mesenchymal stem cells |
Phase I/II; N = 30 |
The immune function (TNF-α 、IL-1β、IL-6、TGF-β、IL-8、PCT、CRP) (Time frame: Observe the immune function of the participants within 4 weeks); Blood oxygen saturation (Time frame: Monitor blood oxygen saturation of the participants within 4 weeks) | Recruiting |
| NCT04392778 | Umbilical cord-derived mesenchymal stem cells |
Phase I/II; N = 30 |
Clinical improvement (Time frame: 3 months) | Recruiting |
| NCT04348461 | Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells |
Phase II; N = 100 |
Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate) (Time frame: 28 days); Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate (Time frame: 6 months) | Not yet recruiting |
| NCT04355728 | Human umbilical cord-derived mesenchymal stem cells |
Phase I/II; N = 24 |
Incidence of pre-specified infusion-associated adverse events (Time frame: Day 5); Incidence of Severe Adverse Events (Time frame: 90 days) | Recruiting |
| NCT04362189 | Allogeneic adipose-derived mesenchymal stem cells |
Phase II; N = 100 |
D-dimer (Time frame: screening, day 0, 7, 10); Interleukin-6 (Time frame: screening, day 0, 7, 10); C Reactive protein (Time frame: screening, day 0, 7, 10); Oxygenation (Time frame: screening, day 0, 7, 10); PCR test SARS-CoV-2 (Time frame: Day 0, 3, 7, 10) | Not yet recruiting |
| NCT04371601 | Umbilical cord-derived mesenchymal stem cells |
Early phase I; N = 60 |
Changes of oxygenation index (PaO2/FiO2),blood gas test (Time frame: 12 months) | Active, not recruiting |
| NCT04299152 | Human cord blood stem cells |
Phase II; N = 20 |
Determine the number of Covid-19 patients who were unable to complete SCE Therapy (Time frame: 4 weeks) | Not yet recruiting |
| NCT04393415 | Cord blood stem cells |
Not Applicable; N = 100 |
The number of patients with positive covid 19 who will improve after receiving stem cells (Time frame: 2 weeks) | Not yet recruiting |
| NCT04397796 | Allogenic bone marrow-derived mesenchymal stem cells |
Phase I; N = 45 |
Incidence of AEs (Time frame: 30 days); Mortality (Time frame: 30 days); Death (Time frame: 30 days); Number of ventilator-free days (Time frame: 60 days) | Not yet recruiting |
| NCT04293692 | Human umbilical cord mesenchymal stem cells |
Not Applicable; N = 0 |
Size of lesion area by chest imaging (Time frame : At baseline, Day 1, Week 1, Week 2, Week 4, Week 8); Blood oxygen saturation (Time frame : At baseline, Day 1, Week 1, Week 2, Week 4, Week 8) | Withdrawn |
| NCT04371393 | Allogenic bone marrow-derived mesenchymal stem cells |
Phase III; N = 300 |
Number of all-cause mortality (Time frame: 30 days) | Recruiting |
| NCT04452097 | Human umbilical cord mesenchymal stem cells |
Phase I; N = 9 |
Incidence of infusion-related adverse events (Time frame: Day 3); Incidence of any treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) (Time frame: Day 28) | Not yet recruiting |
| NCT04377334 | Allogeneic bone marrow-derived human mesenchymal stem (stromal) cells |
Phase II; N = 40 |
Lung injury score (Time frame: day 10) | Not yet recruiting |
| NCT04331613 | Differentiated cells obtained from human embryonic stem cells |
Phase I/II; N = 9 |
Adverse reaction (AE) and severe adverse reaction (SAE) (Time frame: Within 28 days after treatment); Changes of lung imaging examinations (Time frame: Within 28 days after treatment) | Recruiting |
| NCT04390139 | Wharton-Jelly mesenchymal stromal cells |
Phase I/II; N = 30 |
All-cause mortality at day 28 (Time frame: Day 28) | Recruiting |
| NCT04341610 | Allogenic adipose-derived mesenchymal stromal cells |
Phase I/II; N = 0 |
Changes in clinical critical treatment index (Time frame: day 7 from randomization) | Withdrawn |
| NCT04400032 | Bone marrow (BM)-mesenchymal stromal cells |
Phase I; N = 9 |
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (Time frame: At time of infusion until one year post-infusion) | Not yet recruiting |
| NCT04398303 | Allogenic human umbilical derived mesenchymal stem cells |
Phase I/II; N = 70 |
Mortality at day 30 (Time frame: 30 days post treatment) | Not yet recruiting |
| NCT04365101 | Natural killer (NK) cells derived from human placental CD34 + cells |
Phase I/II; N = 86 |
Phase 1: Frequency and severity of adverse events (AE) (Time frame: Up to 12 months); Phase 1: Rate of clearance of SARS-CoV-2 (Time frame: Up to 12 months); Phase 1: Rate of clinical improvement (Time frame: Up to 12 months); Phase 2: Time to Clearance of SARS-CoV-2 (Time frame: Up to 28 days); Phase 2: Time to Clinical Improvement by NEWS2 Score (Time frame: Up to 28 days) | Recruiting |
| NCT04389450 | Allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells |
Phase II; N = 140 |
Number of ventilator free days (Time frame: 28 days) | Recruiting |
| NCT03042143 | Human umbilical cord derived CD362 enriched mesenchymal stem cells |
Phase I/II; N = 75 |
Oxygenation index (OI) (Time frame: Day 7); Incidence of Serious Adverse Events (SAEs) (Time frame: 28 days) | Recruiting |
| NCT04345601 | Single donor banked bone marrow mesenchymal stromal cells |
Early phase I; N = 30 |
Incidence of unexpected adverse events (Time frame: 28 days post cell infusion); Improved oxygen saturations ≥ 93% (Time frame: Within 7 days of cell infusion) | Not yet recruiting |
| NCT04361942 | Allogenic mesenchymal stem cells (source not defined) |
Phase II; N = 24 |
Proportion of patients who have achieved withdrawal of invasive mechanical ventilation (Time frame: 0–7 days); Rate of mortality (Time frame: 28 days) | Recruiting |
| NCT04269525 | Umbilical cord derived mesenchymal stem cells |
Phase II; N = 16 |
Oxygenation index (Time frame: on the day 14 after enrollment) | Recruiting |
| NCT04333368 | Umbilical cord Wharton's jelly-derived mesenchymal stromal cells |
Phase I/II; N = 40 |
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) | Recruiting |
| NCT04367077 | Multipotent adult progenitor cells (source not defined) |
Phase II/III; N = 400 |
Ventilator-Free Days (Time frame: Day 0 through Day 28); Safety and Tolerability as measured by the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0. (Time frame: Day 28) | Recruiting |
| NCT04445220 | Allogenic human mesenchymal stromal cells (source not defined) |
Phase I/II; N = 24 |
Safety and tolerability as measured by incidence of IP-related serious adverse events (Time frame: Outcomes and Serious adverse events through Day 180) | Not yet recruiting |
| NCT04397471 | Allogenic bone marrow derived mesenchymal stromal cells | Not applicable; N = 10 | Determine feasibility of recruiting healthy volunteers in a clinically useful timeframe. (Time frame: 3 or more participants recruited in 1 month); Manufacture a cell-based product suitable for clinical use (Time frame: successfully opening the next phase of the trial in approx. 2 months) | Not yet recruiting |