Umbilical Cord Mesenchymal Stem Cells Transplantation in the Treatment of Chronic Obstructive Pulmonary Disease

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04433104
• Other study ID #: VinmecISC1916
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 9, 2020
• Est. completion date: December 25, 2022

Study information

• Verified date: June 2024
• Source: Vinmec Research Institute of Stem Cell and Gene Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 25, 2022
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosed with COPD with stage B, C, or D according to GOLD 2019.

• Age between 40-75 years old.

• Both genders.

Exclusion Criteria:

• Smoker or less than 6 months of smoking cessation time.

• Asthma and other pulmonary-related diseases and injuries (including lung tuberculosis, restrictive lung disease, idiopathic pulmonary fibrosis, or lung cancer).

• Acute and/or active infection.

• Cancer.

• Patients with complex cardiovascular diseases (including valvular heart disease, cardiomyopathy, arrhythmia, congenital heart disease, hypertrophy syndrome).

• Liver and kidney failure.

• Pregnancy.

• Patients with life expectancy less than 6 months due to concomitant illness.

• Under immunosuppressive treatment within 8 weeks of the first screening visit.

• Patient diagnosed diabetes with HbA1C>7%

Related Conditions & MeSH terms

• COPD
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Biological:
• Umbilical Cord Mesenchymal Stem Cells transplantation
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

Drug:
• drug therapy according to Vietnamese MOHS procedure
Salbutamol, Terbutaline

Locations

Country	Name	City	State
Vietnam	Vinmec International Hospital Times City	Hà N?i	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Vinmec Research Institute of Stem Cell and Gene Technology

Country where clinical trial is conducted

Vietnam, 

References & Publications (3)

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/ — View Citation

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: — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Chest CT	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
Secondary	arterial blood gas analysis (pH)	arterial blood gas analysis (pH)	up to the 12-month period following treatment
Secondary	arterial blood gas analysis (PaO2)	arterial blood gas analysis (PaO2)	up to the 12-month period following treatment
Secondary	arterial blood gas analysis (PaCO2)	arterial blood gas analysis (PaCO2)	up to the 12-month period following treatment
Secondary	arterial blood gas analysis (BE)	arterial blood gas analysis (BE)	up to the 12-month period following treatment
Secondary	arterial blood gas analysis (HCO3-)	arterial blood gas analysis (HCO3-)	up to the 12-month period following treatment
Secondary	Respiratory functions (FEV1)	Respiratory functions (FEV1)	up to the 12-month period following treatment
Secondary	Respiratory functions (FEV1/FVC)	Respiratory functions (FEV1/FVC)	up to the 12-month period following treatment
Secondary	Respiratory functions (VC)	Respiratory functions (VC)	up to the 12-month period following treatment
Secondary	Respiratory functions (TLC)	Respiratory functions (TLC)	up to the 12-month period following treatment
Secondary	Respiratory functions (RV)	Respiratory functions (RV)	up to the 12-month period following treatment
Secondary	Respiratory functions (DLCO)	Respiratory functions (DLCO)	up to the 12-month period following treatment
Secondary	Respiratory functions (DLNO/DLCO)	Respiratory functions (DLNO/DLCO)	up to the 12-month period following treatment
Secondary	inflammatory response (CRP)	inflammatory response (CRP)	up to the 12-month period following treatment
Secondary	inflammatory response (Pro-BNP)	inflammatory response (Pro-BNP)	up to the 12-month period following treatment
Secondary	inflammatory response (Troponin-T)	inflammatory response (Troponin-T)	up to the 12-month period following treatment
Secondary	cytokine analysis from patients' plasma	cytokine analysis from patients' plasma	up to the 12-month period following treatment
Secondary	modified medical research council	modified medical research council (mMRC)	up to the 12-month period following treatment