Article: Allogeneic umbilical cord-derived mesenchymal stem cell transplantation for treating chronic obstructive pulmonary disease: a pilot clinical study. Le Thi Bich et al. Stem Cell Research & Therapy (2020) 11:60
This open access clinical trial was reviewed and summarized for your benefit by Jermiah Ockunzzi and Bart Rademaker, MD
Chronic obstructive pulmonary disease results from chronic inflammation of the lungs and is the third leading cause of death worldwide. Current treatment strategies offer limited result, whilst research in regenerative medicine is showing promising benefits with various disease processes.
This study is aimed to evaluate the safety and efficacy of umbilical cord derived mesenchymal stem cells for the treatment of COPD.
No infusion related toxicities or adverse reactions were noted. Umbilical cord MSC appears to be safe and can significantly improve moderate to severe COPD and quality of life.
Trial registration:ISRCTN,ISRCTN70443938. Registered 06 July 2019
Keywords: Umbilical cord-derived mesenchymal stem cells, Mesenchymal stem cells, COPD, Chronic obstructive pulmonary disease
Methods / Results
Umbilical cord-derived MSCs were infused at 10^6 cells/kg of expanded allogenic UC-MSCs into twenty patients. MSCs were cultured and expanded using UCSCI technology through Wharton’s jelly and whole umbilical cord tissue (serum-free and xeno-free). After culture, potency dilutions, washing, preparation, and mixture, the MSCs were intravenously transfused for 45 minutes at a maximum rate of 2.0*10^6 cells/min.
Nine of the patients were at stage C of the GOLD classification and eleven were at stage D. In the latest Global Institute for Obstructive Lung Disease (GOLD) criteria (released 2017) stage C patients had between 30-50% FEV1 and stage D patients have between 0-30% FEV1.
Exclusion criteria for patients included current smokers and those within a 6-month period after cessation, those with asthma or another clinically relevant lung disease other than COPD, those on antibiotics, those with a history of cancer, those with cardiac impairment, and those on immunosuppressants.
Patients were evaluated for safety and efficacy of the procedure at 1, 3, and 6 months. Efficacy tests included pulmonary function testing, quality of life indicators, the 6-minute walk test, and systemic inflammation assessments. There were no infusion-related toxicities, major Broncho-pulmonary events, or deaths, leading researchers to conclude that UC-MSCs are safe to deliver.
Clinical outcomes in the study in terms of FEV1% were 34% at baseline, 35% after 1 month, 33% after 3 months, and 33.5% after 6 months. CRP-C, an inflammation marker, were measured in mg/dL, their baseline levels being 3.3, 2.2 after 1 month, 2.4 after 3 months, and 2.3 after 6 months.
The quality of life questionnaires (CAT COPD assessment and mMRC assessment) improved from a score of 10.5 (in CAT) to 2.0; and 1.0 (in mMRC) to 0.0. These results were statistically significant improvements in the QoL assessments and number of pulmonary exacerbations during treatment (which decreased), however, FEV1% and CRP-C levels as well as the 6-minute walk test results did not show statistically significant improvement or worsening. A potential reason for this is that over the course of this time period the patients would have worsened in those measures but the treatment kept them close to baseline instead.
Systemic administration of UC-MSCs appears safe. The initial results also showed that UC-MSCs. transplantation improved mMRC, CAT scores, and number of exacerbations in an older, comorbid population of moderate-to-severe COPD patients with compromised lung function.
These primary results provide an important and significant basis for further clinical investigations of MSCs in patients with COPD
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