Studija sigurnosti i efikasnosti alogenog sekretoma stromalnih stanica ljudske menstrualne krvi za liječenje teških pacijenata sa COVID-19: kliničko ispitivanje faza I i II.
Stem cell research & therapy
Sažetak istraživanja
Pozadina Mezenhimalne stromalne ćelije (MSC) bez ćelija razmatrane su zbog njihovog kapaciteta da moduliraju imuni sistem i suzbijaju citokinske oluje uzrokovane SARS-CoV-2. Ovo prospektivno randomizirano dvostruko slijepo, placebom kontrolirano kliničko ispitivanje imalo je za cilj procjenu sigurnosti i učinkovitosti sekretoma dobivenog iz alogenih stromalnih stanica menstrualne krvi (MenSC) kao tretmana kod pacijenata s teškim oblikom COVID-19.
Metode Pacijenti s teškim oblikom COVID-19 randomizirani su (1:1) na liječenje sekretomom izvedenom iz MenSC ili kontrolnu grupu. Subjekti su primili pet intravenskih infuzija 5 mL sekretoma ili istu zapreminu placeba tokom pet dana i praćeni su sigurnost i efikasnost 28 dana nakon tretmana. Analizirani su neželjeni događaji, laboratorijski parametri, trajanje hospitalizacije, poboljšanje kliničkih simptoma, dinamika zasićenja O 2, broj limfocita i serijski snimci grudnog koša.
Rezultati Sve sigurnosne krajnje tačke su uočene bez neželjenih događaja nakon 72 h injekcije sekretoma. Unutar 28 dana nakon upisa, 7 pacijenata (50%) je intubirano u liječenoj grupi naspram 12 pacijenata (80%) u kontrolnoj grupi. Sveukupno, 64% pacijenata je imalo poboljšane nivoe kiseonika u roku od 5 dana od početka lečenja (broj P+ i CD8+ limfocita od 20% (P = 0,06) i 15% (P zaključci) Po prvi put, ova studija je pokazala da je kod hospitalizovanih pacijenata sa teškim oblikom COVID-19, terapija MenSC-ima izvedena za rekonstituciju imune tajne hipoksije, i smanjenje citokinske oluje, bez štetnih efekata koji se mogu pripisati liječenju, moguće je koristiti ovaj tip liječenja za ozbiljne upalne bolesti pluća u budućnosti Identifikator: NCT05019287 Registrovan 24AGUEST 2021, retrospektivno registrovan, https://clinicaltrials.gov/ct2/show/record/NCT05019287, IRCT20180619040147N02.
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Safety and efficacy study of allogeneic human menstrual blood stromal cells secretome to treat severe COVID-19 patients: clinical trial phase I & II.
Background Cell-free Mesenchymal stromal cells (MSCs) have been considered due to their capacity to modulate the immune system and suppress cytokine storms caused by SARS-CoV-2. This prospective randomized double-blind placebo-controlled clinical trial aimed to assess the safety and efficacy of secretome derived from allogeneic menstrual blood stromal cells (MenSCs) as a treatment in patients with severe COVID-19.
Methods Patients with severe COVID-19 were randomized (1:1) to either MenSC-derived secretome treatment or the control group. Subjects received five intravenous infusions of 5 mL secretome or the same volume of placebo for five days and were monitored for safety and efficacy for 28 days after treatment. Adverse events, laboratory parameters, duration of hospitalization, clinical symptom improvement, dynamic of O 2 saturation, lymphocyte number, and serial chest imaging were analyzed.
Results All safety endpoints were observed without adverse events after 72 h of secretome injection. Within 28 days after enrollment, 7 patients (50%) were intubated in the treated group versus 12 patients (80%) in the control group. Overall, 64% of patients had improved oxygen levels within 5 days of starting treatment (P + and CD8 + lymphocyte counts of 20% (P = 0.06) and 15% (P
Conclusions For the first time, this study demonstrated that in hospitalized patients with severe COVID-19, therapy with MenSCs-derived secretome leads to reversal of hypoxia, immune reconstitution, and downregulation of cytokine storm, with no adverse effects attributable to the treatment. Given these outcomes, it may be possible to use this type of treatment for serious inflammatory lung disease with a mechanism similar to COVID-19 in the future. However, it is necessary to evaluate the safety and efficacy of MenSCs-derived secretome therapy in clinical trials on a larger population of patients. Trial registration ClinicalTrials.gov Identifier: NCT05019287. Registered 24AGUEST 2021, retrospectively registered, https://clinicaltrials.gov/ct2/show/record/NCT05019287 . IRCT, IRCT20180619040147N6. Registered 04/01/2021.
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- DOI
- 10.1186/s13287-022-02771-w
- PMID
- 35255966
- PMCID
- PMC8899458
- Provjereno
- 2026-07-26
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