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. 2021 Apr 1;12(2):330–344. doi: 10.14336/AD.2021.0121

Table 1.

Research progress of COVID-19 therapy based on Adipose-derived Mesenchymal Stem Cells (AD-MSCs) clinical trials.

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.