Table 1.
Clinical trial title | Status | Study subject and endpoints | Type | Population | Patient’ evaluation |
---|---|---|---|---|---|
Autologous Adipose-derived Stem Cells (AdMSCs) for COVID-19. | Not yet recruiting | Demonstrate the safety of proposed three-dose regimen of autologous AdMSCs intravenous infusions (approximately 200 million cells) every three days. |
Phase 2 multi-center, double-blind, randomized, placebo-control clinical trial. | 100 patients who have previously banked their AdMSCs, will receive three doses of autologous AdMSCs (Study groud -SG). 100 patients who have previously banked their AdMSCs will not receive any AdMSC therapy but placebo treatments (Control group -CG). |
Adverse events/severe adverse events, COVID-19 symptoms, SARS-Cov-2 virus test, blood SARS-Cov-2 IgM and IgG antibodies tests, blood cytokine and inflammatory (CRP, IL_6, IL-10, TNFα) tests and disease severity evaluation for 6 months after the last dose of AdMSC infusion for the SG and CG. |
Study of Intravenous Administration of Allogeneic Adipose Stem Cells for COVID-19. | Recruiting | Demonstrate the safety and preliminary efficacy of allogeneic adipose stem cells PSC-04 intravenous infusion of in patients with COVID-19 disease and respiratory distress. | Single arm, non-randomized phase 1 study. | 20 patients (SG) cohort of contemporaneous non-treated patients (CG) |
N/A |
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. | Active, not recruiting | Assess the safety and efficacy of five intravenous infusions of autologous adipose-derived mesenchymal stem cells previously banked to Hope Biosciences lab (HB-adMSCs), in subjects with no signs of COVID-19, to provide immune support against COVID-19. | Phase II, Open Label, Single-Center, Clinical Trial. | 75 patients (SG-CG) |
N/A |
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. | Enrolling by invitation | Provide immune support against COVID-19 measured by the percentage of subjects that develop symptoms of COVID-19. | Phase II, RandomizedPlacebo-Controlled, Double-Blinded, Clinical Trial | 100 patients (SG-CG) Eligible participants are at high or very high exposure risk of contracting COVID-19. |
Participants will be monitored for overall clinical status by standard clinical laboratories and inflammatory markers. Participants will complete Short Form Health Survey (SF-36) and depression module (PHQ-9) questionnaires. |
Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19. | Active, not recruiting | Assess Efficacy of HB-adMSCs to treat COVID-19 patients. Primary endpoints: detect change from baseline in inflammatory markers (IL-6, IL-10, TNF-alpha, C Reactive protein), improving oxygenation, and decreasing time to return to room air (RTRA). |
Phase II, RandomizedPlacebo-Controlled, Double-Blinded, Clinical Trial | 100 patients (SG-CG) Eligible participants are suspected to have COVID-19 and consent to participate. |
Participants will be monitored for overall clinical status by standard clinical laboratories, change from baseline in exploratory markers (D-dimer, myoglobin, troponin, creatinine kinase MB, serum ferritin, CD4:CD8 ratio, CD3-CD56+), time to negative PCR results and clinical improvement according to 7-point ordinal scale, as well as incidence of adverse events. |
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. | Active, not recruiting | Evaluate the safety and efficacy of intravenous administration of Allogenic Adipose Tissue-Derived Mesenchymal Stem Cells Expanded in patients with severe COVID-19 pneumonia. | Phase I/II clinical trial. | 26 patients (SG-CG) |
N/A |
ASC Therapy for Patients with Severe Respiratory COVID-19 | Withdrawn (Not approved by ethical committee) |
Assess the impact of allogeneic ASCs on the activated immune system and clinical efficacy on pulmonary function in COVID-19 patients. | Double-blind, randomized, placebo-control clinical trial. | N/A | N/A |
BAttLe Against COVID-19 Using MesenchYmal Stromal Cells. | Not yet recruiting | Evaluate the safety and efficacy of the intravenous administration of expanded allogeneic adipose tissue adult mesenchymal stem cells, in patients infected with SARS-COV-2 with COVID-19 type complications. | RandomizedControlled, Multicenter Clinical Trial. | 100 patients (SG-CG) |
N/A |
Study to Evaluate the Efficacy and Safety of AstroStem-V in Treatment of COVID-19 Pneumonia. | Not yet recruiting | Evaluate the safety and efficacy of Astrostem-V, allogenic adipose tissue derived mesenchymal stem cells (AdMSC), in patients with COVID-19 pneumonia. | Open-label, single-arm study. | 10 patients (SG) |
Adverse events, physical examination and laboratory test values. |
A Pilot Clinical Study on Inhalation of Mesenchymal Stem Cells Exosomes Treating Severe Novel Coronavirus Pneumonia. | Completed | Explore the safety and efficiency of aerosol inhalation of the exosomes derived from allogenic adipose mesenchymal stem cells (MSCs-Exo) in the treatment of severe patients hospitalized with novel coronavirus pneumonia (NCP). | Single-arm design, open label, combined interventional clinical trial. | 24 patients (SG) |
Adverse reaction and severe adverse reaction, clinical evaluation and laboratory test as Lymphocyte Count, C-reactive protein, Lactate dehydrogenase, D-dimer, pro-type B natriuretic peptide, IL-1β, IL-2R, IL-6, IL-8, chest imaging, time to SARS-CoV-2 RT-PCR negativity. |