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

NCT ID: NCT04433104

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-09
• Study Completion Date: 2022-12-25

Brief 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

Detailed 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

Conditions

COPD

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment (UC-MSC trasnplatation)

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

Group Type: EXPERIMENTAL

Umbilical Cord Mesenchymal Stem Cells transplantation

Intervention Type: 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

drug therapy according to Vietnamese MOHS procedure

Intervention Type: DRUG

Salbutamol, Terbutaline

control arm

drug therapy according to Vietnamese MOHS procedure

Group Type: OTHER

drug therapy according to Vietnamese MOHS procedure

Intervention Type: DRUG

Salbutamol, Terbutaline

Interventions

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

Intervention Type: BIOLOGICAL

drug therapy according to Vietnamese MOHS procedure

Salbutamol, Terbutaline

Intervention Type: DRUG

Eligibility Criteria

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%

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vinmec Research Institute of Stem Cell and Gene Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Duc Minh Hoang, PhD

Role: PRINCIPAL_INVESTIGATOR

Vinmec Research Institute of Stem Cell and Gene Technology

Locations

Vinmec International Hospital Times City

Hanoi, Hanoi, Vietnam

Countries

Vietnam

References

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.

Reference Type: RESULT

PMID: 21311694 (View on PubMed)

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.

Reference Type: RESULT

PMID: 24255620 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26819296 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33986057 (View on PubMed)

Other Identifiers

VinmecISC1916

Identifier Type: -

Identifier Source: org_study_id