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This trial is to investigate the safety and potential therapeutic efficacy of allogeneic administration of umbilical cord-derived MSCs (UC-MSCs) as a supplementary intervention in combination with standard COPD medication treatments in patients with moderate-to-severe COPD based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 and Vietnam Ministry of Health's guidelines
The aim of this trial is to investigate the safety and potential therapeutic efficacy of allogeneic administration of umbilical cord-derived MSCs (UC-MSCs) as a supplementary intervention in combination with standard COPD medication treatments in patients with moderate-to-severe COPD based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 and Vietnam Ministry of Health's guidelines. This matched case-control phase I/II trial is conducted at Vinmec Times City International Hospital, Hanoi, Vietnam between June 2020 and December 2021. In this study, 40 patients will be enrolled and assigned into two age-, gender- and COPD condition-matched groups, including a UC-MSC group and a control group. Both groups will receive standard COPD medication treatment based on the GOLD 2019 guidelines and the Vietnam Ministry of Health protocol. The UC-MSC group will receive two doses of thawed UC-MSC product with an intervention interval of 3 months. The primary outcome measures will include the incidence of prespecified administrationassociated adverse events (AEs) and serious adverse events (SAEs). The efficacy will be evaluated based on the absolute changes in the number of admissions, arterial blood gas analysis, lung function and lung fibrosis via CT scan and chest X-ray. The clinical evaluation will be conducted at baseline and 3, 6, and 12 months post
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (UC-MSC trasnplatation) | Experimental | 1 x 10^6 umbilical Cord Mesenchymal Stem Cells per body kg will transplant via the intravenous at baseline, and the second transplantation will be performed 3 months after the first transplantation and combination with Vietnames MOH procedure |
|
| control arm | Other | drug therapy according to Vietnamese MOHS procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical Cord Mesenchymal Stem Cells transplantation | Biological | Patients assigned to UC-MSC administration groups will receive two administrations at a dose of 1 million cells/kg patient body weight via the IV route with a 3-month intervening interval |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and serious adverse events | To assess safety, the number of AEs or SAEs during stem cell administration (72 h) at 3 months, 6 months, and 12 months after discharge will be evaluated | up to the 12-month period following treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life using Georges Respiratory Questionnaire | Georges Respiratory Questionnaire has scores range from 0 to 100, with higher scores indicating more limitations | up to the 12-month period following treatment |
| Chest CT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Duc Minh Hoang, PhD | Vinmec Research Institute of Stem Cell and Gene Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vinmec International Hospital Times City | Hanoi | Hanoi | 100000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21311694 | Result | Ribeiro-Paes JT, Bilaqui A, Greco OT, Ruiz MA, Marcelino MY, Stessuk T, de Faria CA, Lago MR. Unicentric study of cell therapy in chronic obstructive pulmonary disease/pulmonary emphysema. Int J Chron Obstruct Pulmon Dis. 2011 Jan 1;6:63-71. doi: 10.2147/COPD.S15292. | |
| 24255620 | Result | Stessuk T, Ruiz MA, Greco OT, Bilaqui A, Ribeiro-Paes MJ, Ribeiro-Paes JT. Phase I clinical trial of cell therapy in patients with advanced chronic obstructive pulmonary disease: follow-up of up to 3 years. Rev Bras Hematol Hemoter. 2013;35(5):352-7. doi: 10.5581/1516-8484.20130113. |
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| drug therapy according to Vietnamese MOHS procedure | Drug | Salbutamol, Terbutaline |
|
Changes of the lung fibrosis on chest CT at 6 months, and 12 months compared with baseline
| up to the 12-month period following treatment |
| arterial blood gas analysis (pH) | arterial blood gas analysis (pH) | up to the 12-month period following treatment |
| arterial blood gas analysis (PaO2) | arterial blood gas analysis (PaO2) | up to the 12-month period following treatment |
| arterial blood gas analysis (PaCO2) | arterial blood gas analysis (PaCO2) | up to the 12-month period following treatment |
| arterial blood gas analysis (BE) | arterial blood gas analysis (BE) | up to the 12-month period following treatment |
| arterial blood gas analysis (HCO3-) | arterial blood gas analysis (HCO3-) | up to the 12-month period following treatment |
| Respiratory functions (FEV1) | Respiratory functions (FEV1) | up to the 12-month period following treatment |
| Respiratory functions (FEV1/FVC) | Respiratory functions (FEV1/FVC) | up to the 12-month period following treatment |
| Respiratory functions (VC) | Respiratory functions (VC) | up to the 12-month period following treatment |
| Respiratory functions (TLC) | Respiratory functions (TLC) | up to the 12-month period following treatment |
| Respiratory functions (RV) | Respiratory functions (RV) | up to the 12-month period following treatment |
| Respiratory functions (DLCO) | Respiratory functions (DLCO) | up to the 12-month period following treatment |
| Respiratory functions (DLNO/DLCO) | Respiratory functions (DLNO/DLCO) | up to the 12-month period following treatment |
| inflammatory response (CRP) | inflammatory response (CRP) | up to the 12-month period following treatment |
| inflammatory response (Pro-BNP) | inflammatory response (Pro-BNP) | up to the 12-month period following treatment |
| inflammatory response (Troponin-T) | inflammatory response (Troponin-T) | up to the 12-month period following treatment |
| cytokine analysis from patients' plasma | cytokine analysis from patients' plasma | up to the 12-month period following treatment |
| modified medical research council | modified medical research council (mMRC) | up to the 12-month period following treatment |
| 26819296 | Result | Stolk J, Broekman W, Mauad T, Zwaginga JJ, Roelofs H, Fibbe WE, Oostendorp J, Bajema I, Versteegh MI, Taube C, Hiemstra PS. A phase I study for intravenous autologous mesenchymal stromal cell administration to patients with severe emphysema. QJM. 2016 May;109(5):331-6. doi: 10.1093/qjmed/hcw001. Epub 2016 Jan 27. |
| 33986057 | Derived | Hoang DM, Nguyen KT, Nguyen AH, Nguyen BN, Nguyen LT. Allogeneic human umbilical cord-derived mesenchymal stem/stromal cells for chronic obstructive pulmonary disease (COPD): study protocol for a matched case-control, phase I/II trial. BMJ Open. 2021 May 13;11(5):e045788. doi: 10.1136/bmjopen-2020-045788. |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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