Study of Intravenous Administration of Allogeneic Adipose Stem Cells for COVID-19

  • Researchers from Sorrento Therapeutics in Fresno, California are preparing a study to test the safety and efficacy of their product PSC-04. This product is an adipose-derived mesenchymal stem cell treatment. There will be 20 participants all in the treatment group.
  • NCT04486001

 

Mesenchymal Stem Cells in Patients Diagnosed with COVID-19

  • Researchers in Mexico are looking for volunteers for a trial testing the safety and efficacy of adipose-derived mesenchymal stem cells as a treatment for patients with COVID-19. There will be 10 treatment volunteers and 10 control volunteers. The control volunteers will receive standard care while the treatment volunteers will receive MSC infusions of 1×10^6 cells/ kg of body on day 1 and day 3. The progress of patients will be monitored through X-rays as well as checking for biomarkers such as C-reactive protein, immune cells, pro-inflammatory cytokines, and Immunoglobulins.
  • NCT04611256

 

Regenerative Medicine for COVID-19 and Flu-Elicited ARDS using Longeveron Mesenchymal Stem Cells

  • Researchers from Longeveron are looking for volunteers to test with safety and efficacy of their Longeveron mesenchymal stem cells. There will be 25 treatment subjects and 10 control subjects separated into 2 cohorts. The first cohort will be patients who have ARDS due to COVID-19 and the second cohort will be patients who have ARDS due to the flu. They will both receive the same treatment. The control group will simply receive a placebo. The treatment group will receive an infusion of up to 100 million MSCs on days 0, 3, and 6.
  • NCT04629105

ChiCTR2000031319

  • Safety and Efficacy Study of Allogenic Human Dental Pulp Mesenchymal Stem Cells to Treat Severe Pneumonia of COVID-19
  • Researchers in Wuhan, China are researching the safety and efficacy of using allogeneic human dental pump mesenchymal stem cells as a treatment of severe pneumonia caused by COVID-19. The trial involves a control group with 10 participants and a treatment group with 10 participants. The control will receive treatment and placebo and the treatment group will receive treatment and intravenous injection of human dental pulp stem cells. Patients must consent to blood, fecal, and urine tests. Researchers are looking for TTCI, immune biomarkers, degree of participants’ lung lesions, time it takes for COVID test to turn negative, blood oxygen Levels, and other biochemical tests as primary and secondary indicators of the trial.
    • Results should be posted within 6 months of trial completion, trial ended on 7/31/2020

ChiCTR2000031139

  • Safety and Effectiveness of Human embryonic stem cell-derived M cells (CAStem) for Pulmonary Fibrosis Correlated with novel coronavirus pneumonia (COVID-19) 
  • Researchers in Wuhan, China are currently recruiting participants for a trial to test the safety and efficacy of human embryonic stem cell-derived M cells for Pulmonary Fibrosis caused by COVID-19 pneumonia. This trial will have a 20-person test group that will receive 3×10^6 cells/kg once a week for 2 or 3 weeks. The patients must consent to collection of their blood and respiratory secretions. The indicators the researchers are looking for include: pulmonary function evaluations, changes in blood gas analysis, evaluations of activity, dyspnea, life quality, and mental health, CT scan changes, and blood immune factor tests.
    • Results will be posted 6 months after trial completion on 3/19/2021

ChiCTR2000030944

  • Clinical study of human NK cells and MSC’s transplantation for severe novel coronavirus pneumonia (COVID-19)
  • Researchers in Jiangxi, China are recruiting patients for clinical trials to explore the safety and efficacy of Natural Killer Cells and Mesenchymal Stem cells as a treatment for severe pneumonia caused by COVID-19. There will be a 10-person experimental group and a 10-person control group. The control group will simply receive normal treatment and the experimental group will receive normal treatment with an increased level of NK’s and MSC’s. Patients must consent to blood sample collections. The researchers are looking for indicators that include: changes of serum inflammatory factors, patient death risk, and drug related adverse reactions and events.
    • Results will be posted 6 months after trial completion which was 8/31/2020

    ChiCTR2000030173

    • Key techniques of umbilical cord mesenchymal stem cells for the treatment of novel coronavirus pneumonia (COVID-19) and clinical application demonstration
    • Researchers in Hu’nan, China are researching the safety and effectiveness of using umbilical cord derived MSC’s to treat COVID-19 pneumonia. There will be a 30-person experimental group and a 30-person control group. The control group will receive normal treatment and the experimental group will receive normal treatment with umbilical cord derived MSC’s. Patients must consent to blood sample collection. The indicators the researchers are looking for are: pulmonary function, novel coronavirus pneumonic nucleic acid tests, a pulmonary CT, and chest radiography.
      • Results are meant to made available in real-time, no indication where these will be posted.

    ChiCTR2000030088

    • Umbilical cord Wharton’s Jelly derived mesenchymal stem cells in the treatment of severe novel coronavirus pneumonia (COVID-19)
    • Researchers in Beijing, China are investigating the safety and efficacy of umbilical cord derived Wharton’s jelly MSC’s as an intravenous treatment of COVID-19 pneumonia. There will be a 20-person experimental group and a 20-person control group. The control group will receive IV saline and the experimental group will receive an IV injection of 1×10^6/kg cells of Wharton’s jelly mesenchymal stem cells in 40 ml. Patients must consent to sample collections of throat secretion and venous blood. The indicators researchers are looking for include: a negative nucleic acid test for COVID and that the CT scan of the participants’ ground glass shadow disappears.
    • From their application: “MSC’s on macrophages (MC), conversion of inflammatory M1 M2 for anti-inflammatory type, direct inhibition of alveoli and interstitial lung immune ultra-inflammation, restrain activity of lymphocytes and proliferation, inhibition of lung tissue and interstitial tissue excessive immune response, mobilization and proliferation neutrophils and monocytes, macrophages, natural killer (NK) cell line such as inherent immune cell to gobble up the virus, the immune ultra, MSC’s suppress the immune overreaction, coordinate the immune balance, reverse repair of pulmonary epithelial cells and extracellular interstitial immunoregulation for severe novel coronavirus pneumonia, especially in patients with advanced ARDS, shock and DIC.”
      • Results will be posted 6 months after 12/31/2020

    ChiCTR2000030020

    • The clinical application and basic research related to mesenchymal stem cells to treat novel coronavirus pneumonia (COVID-19) 
    • Researchers in Hu’nan, China are researching the safety and efficacy of mesenchymal stem cells to treat coronavirus pneumonia. There will only be a 20-person experimental group. The experimental group will receive treatment with mesenchymal stem cells. The participants must consent to throat swabs and blood sample collection. The indicators researchers will be examining include: the negativity rate of COVID nucleic acid markers, trough and peak of pulmonary function FEV1, lymphocyte subpopulation changes, whether or not symptoms improve after 4 treatments, and inflammation as shown by a CT of the chest.
      • Results will be available 6 months after 2/5/2022

    ChiCTR2000029606

    • Clinical Study for Human Menstrual Blood-Derived Stem Cells in the Treatment of Acute Novel Coronavirus Pneumonia (COVID-19) 
    • Researchers in Zhejiang, China are researching the safety and efficacy of a menstrual blood-derived stem cells as a treatment for coronavirus pneumonia. This study involves an experimental group A (18 people), B1(10), and B2(10) as well as a control group A(25). The control group will receive conventional treatment. Experimental group A will receive conventional treatment and intravenous infusion of menstrual blood-derived stem cells. Experimental group B1 will receive conventional treatment and artificial liver therapy. Experimental group B2 will receive conventional treatment, intravenous infusion of menstrual blood-derived stem cells, and artificial liver therapy. Patients must consent to blood sample collection. The indicators researchers are looking for include mortality in patients, improvement rate in patients, incidence of shock, incidence of multiple organ failure, days in hospital, days in ICU, non-invasive ventilation modes and parameters, intubation-assisted ventilation modes and parameters, and extracorporeal membrane oxygenation patterns and parameters.
      • Results should be available 6 months after 12/31/2022

     

    ChiCTR2000029580

    • Severe novel coronavirus pneumonia (COVID-19) patients treated with ruxolitinib in combination with mesenchymal stem cells: a prospective, single blind, randomized controlled clinical trial
    • Researchers in Hubei, China are recruiting volunteers to research the safety and efficacy of using ruxolitinib in combination with mesenchymal stem cells as a treatment for patients that have severe COVID-19 pneumonia. The trial involves a control group with 35 participants and a treatment group with 35 participants. The control will receive traditional treatment and the treatment group will receive treatment with ruxtolitinib and mesenchymal stem cells. Patients must consent to blood and urine tests. The researchers will be collecting data to study safety and efficacy as well as monitor quality of life changes for the patients or improvements in possible long-term damage.
      • Data from these trials will be available at the end of 2021

    ChiCTR2000030116

    • 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) 
    • Researchers in Jiangxi, China are researching the safety and efficacy of umbilical cord mesenchymal stem cells as a treatment for COVId-19 induced pneumonia and respiratory distress syndrome. The trial involves 2 16-person treatment groups who will receive varying amounts of stem cells. Patients must consent to collection of their blood samples. The researchers’ primary outcome will be focusing on the time it takes for patients to be taken off of a ventilator after receiving treatment.
      • Data from these trials will be available 6 months after the completion date of 08/31/2020

    ChiCTR2000030484

    • HUMSC’s and Exosomes Treating Patients with Lung Injury following Novel Coronavirus Pneumonia (COVID-19)
    • Researchers in Hubei, China are researching the safety and efficacy of using exosomes and human umbilical cord derived mesenchymal stem cells (HUMSCs) as a treatment for COVID-19 pneumonia. This trial has 2 30-person treatment groups and 1 30-person control group. The first treatment group will receive an intravenous infusion of 5x 10^7 HUMSCs once a week for 2 weeks. The second treatment group will receive an intravenous infusion of 5x 10^7 HUMSCs once a week for 2 weeks as well as intravenous administration of 180mg of exosomes every day for 2 weeks. The control group will simple receive an infusion of a placebo. Patients in this trial must consent to a blood sample collection. The primary outcomes that the researchers are monitoring include: Pa02/FiO2 or respiratory rate, frequency of respiratory exacerbation, observing and recording clinical recovery time, the number and range of lesions indicated by CT and X-Ray of lung, time for cough to become mild/absent, frequency of noninvasive inhalation, frequency of mechanical inhalation, time for dyspnea to become mild/absent, inflammatory cytokines, and frequency of serious adverse events.
      • No data available at this time

    ChiCTR2000030866

    • Open-label, observational study of human umbilical cord derived mesenchymal stem cells in the treatment of severe and critical patients with novel coronavirus pneumonia (COVID-19)
    • Researchers in Changsha, China are researching the safety and efficacy of umbilical cord derived mesenchymal stem cells as treatment for patients with COVID-19 pneumonia. This treatment has 1 30-person treatment group. The treatment group will receive intravenous infusion of stem cells “based on conventional treatments”. Patients must consent to blood sample collections and throat swabs. The primary indicators being researched are” oxygenation index, conversion rate from serious to critical patients, and mortality rate.
      • Data will be posted 6 months after the trial completion date of 12/31/2020

    ChiCTR2000030835

    • Clinical study for the efficacy of mesenchymal stem cells (MSC’s) in the treatment of severe novel coronavirus pneumonia (COVID-19)
    • Researchers in He’nan, China are researching the safety and efficacy of umbilical cord derived mesenchymal stem cells as treatment for COVID-19 pneumonia. This trial will have 2 treatment groups. The first treatment group will receive routine treatment and intravenous infusion of 1×10^6 MSCs/kg of MSCs once every 3 days. The second treatment group will receive routine treatment and intravenous infusion of 2×10^6 MSCs/kg of MSC’s once every 3 days. Patients must consent to collection of blood samples. Researchers will be focusing on the following indicators: C-reactive protein, detection of lymphocyte subsets, urinalysis, procalcitonin, routine blood tests, chest CT scans, cytokines, and blood biochemistry.
      • No data is currently available

    NCT04315987

    • NestaCell® (mesenchymal stem cell) to treat severe COVID-19 pneumonia
    • Researchers in San Paulo, Brazil are planning to research the safety and efficacy of NestaCell, a mesenchymal stem cell therapy, as treatment for COVID-19 pneumonia. This trial will have 90 total participants, split into treatment and control groups. The treatment group will receive IV administration of 2×10^7 cells on days 1, 3, 5, and 7 of treatment. The control group will receive an IV administration of a placebo on the same schedule. Patients must consent to full blood counts as well as cardia, hepatic, and renal profiles. The outcome measures researchers will be focusing on include: change in clinical condition, rate of mortality within 10 days, change in respiratory rate, hypoxia, PaO2/FiO2 ratio, CD4+ and CD8+ cell count, changes in blood oxygen, as well as general side effects.
      • This study has not begun recruiting yet

     

    NCT04313322

    Treatment of COVID-19 Patients Using Wharton’s Jelly-Mesenchymal Stem Cells

    • Researchers in Jordan are recruiting for a trial to research the safety and efficacy of Wharton’s Jelly Mesenchymal stem cells as a treatment for COVID-19. This trial will only have a 5-person treatment group. The patients will receive an IV dose of 1×10^6/kg MSCs every 3 days for a total of 3 doses. The outcome measures researchers will be focusing on include: improvement of COVID symptoms, CT scans, and PT-PCR results.
      • This study is currently recruiting volunteers

    NCT04302519

    • Novel Coronavirus Induced Severe Pneumonia Treated by Dental Pulp Mesenchymal Stem Cells
    • Researchers in Shanghai are planning to research the safety and efficacy of dental pulp mesenchymal stem cells as treatment for COVId-19 induced pneumonia. This trial will have one 24-person treatment group. The treatment group will receive 1×10^6 MSCs/kg of body weight on days 1, 3, and 7 of the trial. The outcome measures the researchers will be focusing on include time it takes for ground-glass shadow to disappear from the lungs, absorption of lung shadow by chest CT Scan, and changes in blood oxygen.
      • This study is not yet recruiting volunteers

    NCT04288102

    • Treatment with Human Umbilical Cord-derived MSC’s for Sever Corona Virus Disease 2019
    • Researchers in Beijing, China have recently completed trials testing the safety and efficacy of umbilical cord-derived MSC’s as treatment for COVID-19. This trial will have 60 patients in the treatment group and 30 patients in the control group. The treatment group will receive 1 dose of 4×10^7 MSCs on days 0, 3, and 6 of the trial. The control group will receive a placebo on this same time schedule. Researchers will be focusing on the following outcome measures: change in lesion proportion of full lung volume from baseline to days 10 & 90, pulmonary fibrosis as shown on CT scan, lung densitometry, clinical improvements, oxygenation index, duration of oxygen therapy, blood oxygen saturation, a 6-minute walk test, maximum vital capacity, diffusing capacity, dyspnea, changes in lymphocyte count, changes in cytokine/chemokine levels, adverse effects, and mortality.
      • This trial has been completed but results have not been posted

    NCT04252118

    • Safety and Efficiency of Mesenchymal Stem Cell in Treating Pneumonia Patients Infected With COVID-19
    • Researchers in Beijing, China are currently recruiting patients for a trail testing the safety and efficacy of mesenchymal stem cells as a treatment for COVID-19 pneumonia. This trial will have a 10-person treatment group and a 10-person control group. The treatment group will receive conventional treatment and one dose of 3×10^7 MSCs on days 0, 3, and 6 of the trial. The control group will only receive conventional treatment. The researchers will be monitoring the following outcome measures: size of lesion area as shown by CT scan or chest radiography, side effects in treatment group, improvement of clinical symptoms, time for a negative test, rate of mortality, CD4+ & CD8+ cell counts, alanine aminotransferase, C-reactive protein, and creatine kinase.
      • This study is currently recruiting

    NCT04299152

    • Clinical Application of Stem Cell Educator Therapy for the Treatment of Viral Inflammation Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
    • Researchers from Tianhe Stem Cell Biotechnologies are planning to research the safety and efficacy of their Stem Cell Educator technology as a treatment for patients infected with COVID-19. The Stem Cell Educator Technology utilizes human multipotent cord blood stem cells. This trial will include 20 participants split into an experimental and a no intervention group. The experimental group will receive treatment with the stem cell educator technology. The no intervention group will receive regular treatments. The researchers will be monitoring the following outcome measures: examining how many patients cannot undergo the SCE technology treatment, examining the percentage of activated T cells, assessing the percentage of th17 cells, chest imaging by CT scan, and quantification of the COVID viral load by real time PT-PCR.
      • This study is not yet recruiting

    NCT04269525

    • Clinical Research Regarding the Availability and Safety of UC-MSCs Treatment for Serious Pneumonia and Critical Pneumonia Caused by the 2019-nCOV Infection
    • Researchers from Wuhan, China are recruiting volunteers for a study investigating the safety and efficacy of umbilical cord derived MSCs as a treatment for COVID-19 pneumonia. This study will have a 16-person treatment group. The treatment group will receive 3.3×10^7 MSC’s intravenously on days 1, 3, 5, and 7 of the trial. The outcome measures the researchers will be focusing on include: oxygenation index, mortality, length of hospital stay, COVID nucleic acid & antibody test, improvement of lung imaging examinations, white blood cell count, lymphocyte count, procalcitonin, IL-2,4,6,10, TNF-A, IFN, CRP, CD4+, CD8+, and natural killer cells.
      • This study is currently recruiting

    NCT04276987

    • A Pilot Clinical Study on Aerosol Inhalation of the Exosomes Derived From Allogenic Adipose Mesenchymal Stem Cells in the Treatment of Severe Patients With Novel Coronavirus Pneumonia
    • Researchers from Wuhan, China have recently completed trials investigating allogenic adipose mesenchymal stem cell-derived exosomes as a inhalable treatment for COVID-19 pneumonia. This trial had a 24-person treatment group. The treatment group inhaled 2×10^8 MSC’s-derived exosomes on days 1, 2, 3, 4, and 5 of the trial. The researchers were focused on the following clinical outcome measures: adverse reactions, time to clinical improvement, number of patients being taken off ventilators, duration of ICU monitoring, duration of vasoactive agents’ usage, number of patients with improved organ failure, and rate of mortality.
      • This trial has been completed and expanded into further trials, but no results have been posted

    NCT04646603

    • MRG-001 as an Immunoregulatory and Regenerative Therapy for COVID-19 Patients

    Researchers for MedRegen LLC are preparing a clinical trial to study the safety and efficacy of their MRG-001 drug as a treatment for COVID-19 patients. MRG-001 is a drug that is administered as a subcutaneous injection and has shown in studies that it mobilizes and recruits stem cells & immunoregulatory cells to promote tissue regeneration. This trial will have 18 participants blindly placed into 3 experimental and 3 placebo groups. The experimental groups will receive either 0.005, 0.01, or 0.02 mL/kg of MRG-001 every other day for 5 days (total of 3 injections). The placebo group will receive the same treatment but with a placebo saline injection.

     

     

     

    NCT04466098

    • Multiple Dosing of Mesenchymal Stromal Stem Cells in Patients with ARDS (COVID-19)

    Researchers at the University of Minnesota are recruiting patients for a Phase II trial to study the safety and efficacy of multi-dosing patients with COVID-induced ARDS. This trial will have 20 experimental patients and 10 placebo patients. The experimental patients will receive 300×10^6 MSC in 3 fixed dosed 48 hours apart. The placebo group will receive placebo doses over the same time interval.

     

    NCT04361942

    • Treatment of Severe COVID-19 Pneumonia with Allogenic Mesenchymal Stromal Cells

    Researchers in Spain are looking for volunteers for a study to test the safety and efficacy of Mesenchymal Stromal Cells as a treatment for COVID-19 Pneumonia. The trial will have 12 experimental patients and 12 placebo patients. The experimental patients will receive an intravenous injection of 1 million MSV cells/Kg. The placebo group will receive a placebo injection.

     

    NCT04333368

    • Cell Therapy Using Umbilical Cord-derived Mesenchymal Stromal Cells in SARS-CoV-2-related ARDS

    Researchers in Paris, France, are looking for volunteers to participate in a trial testing the safety and efficacy of Umbilical cord Wharton’s jelly-derived Mesenchymal Stem cells as a treatment for COVID-induced ARDS. The trial will have 20 experimental patients and 20 placebo patients. The experimental group will receive 1 million MSC/kg on days 1, 3, and 5. The placebo group will receive a placebo injection over the same interval.

     

    NCT03042143

    • Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration

    Researchers in Ireland are looking for participants in a clinical trial testing the safety and efficacy of umbilical cord derived CD362 enriched MSCs. In phase 1 of this trial, they determined that 400 million cells to be the maximum dose for this treatment, so they will be using that amount for this phase 2 study. There will be 75 participants in this study separated into experimental and placebo groups. The experimental group will receive an infusion of the 400 million MSC dose and the placebo group will receive a placebo infusion.

     

     

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