1️⃣ Treatment of severe Corona Virus Disease 2019 (COVID-19) is challenging. We performed a phase 2 trial to assess the efficacy and safety of human umbilical cord-mesenchymal stem cells (UC-MSCs) to treat severe COVID-19 patients with lung damage, based on our phase 1 data.

2️⃣ UC-MSCs treatment is a safe and potentially effective therapeutic approach for COVID-19 patients with lung damage. (Funded by The National Key R&D Program of China and others. ClinicalTrials. gov number, NCT04288102.)

3️⃣ Mesenchymal stem cells (MSC) are non-hematopoietic cells with immune modulatory, regenerative, and differentiation properties. MSC treatment reduced the pathological changes of the lung and inhibits the cell-mediated immune-inflammatory response induced by the influenza virus in animal models and clinical trials. The safety and potential efficacy of MSC have also been evaluated in the patients with acute respiratory distress syndrome (ARDS). The immunomodulatory and regenerative properties of MSCs offer potential cellular therapeutic option for limiting lung damage in patients with COVID-19 and require evaluation in randomized controlled.

4️⃣ The Wharton’s Jelly (WJ) tissues were cut into approximately 2 mm3 pieces from cord tissue and planted upside down on tissue culture flasks (75􀀀cm2) cultured in DMEM/F12, supplemented with fetal bovine serum (10% FBS, BI, Israel) at 37°C with 5% CO2. The adherent cells were detached with 1×TrypLE (GIBCO, USA) and then re-plated at a density of approximately 6-8×103 cells/cm2 for further expansion. Master cell bank at passage 2 and working cell bank at passage 4 were set separately. A homogenous population of cultured cells at passage 5 were prepared as UC-MSC product. The cell product has been certified by the National Institutes for Food and Drug Control of China.

5️⃣ Our current trial showed that UC-MSCs therapy improved the resolution of the whole lung damage size, as detected by CT scanning, particularly the solid component lesions. This finding indicated that UC-MSC administration has a therapeutic benefit for patients with COVID-19, even in the convalescent stage. It is known that the solid component lesions in the lung include the interstitial fibrosis. Thus, the improvements of solid component lesions might also imply the alleviation of lung fibrosis.

Treatment with human umbilical cord-1 derived mesenchymal stem cells for COVID-19 patients with lung damage: a randomised, double-blind, placebo-controlled phase 2 trial

[By Celebre Pro Medic Sdn Bhd 20211224]

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