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

NCT04433104 | Completed Phase 1 DMC

• 1 other identifier: VinmecISC1916
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

COPD

Keywords

COPD; umbilical cord mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Quality of Life using Georges Respiratory Questionnaire

  up to the 12-month period following treatment

• Chest CT

  up to the 12-month period following treatment

• arterial blood gas analysis (pH)

  up to the 12-month period following treatment

• arterial blood gas analysis (PaO2)

  up to the 12-month period following treatment

• arterial blood gas analysis (PaCO2)

  up to the 12-month period following treatment

Study Arms (2)

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

Biological: Umbilical Cord Mesenchymal Stem Cells transplantation; Drug: drug therapy according to Vietnamese MOHS procedure

control arm

OTHER

drug therapy according to Vietnamese MOHS procedure

Drug: drug therapy according to Vietnamese MOHS procedure

Interventions

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

Treatment (UC-MSC trasnplatation)

drug therapy according to Vietnamese MOHS procedure DRUG

Salbutamol, Terbutaline

Treatment (UC-MSC trasnplatation); control arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with COPD with stage B, C, or D according to GOLD 2019.
• Age between 40-75 years old.
• Both genders.

You may not qualify if:

• 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%

Sponsors & Collaborators

• Vinmec Research Institute of Stem Cell and Gene Technology: lead

Study Sites (1)

Vinmec International Hospital Times City

Hanoi, Hanoi, 100000, Vietnam

Location

Related Publications (4)

• 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.

  PMID: 21311694 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.

  PMID: 24255620 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.

  PMID: 26819296 RESULT

• 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.

  PMID: 33986057 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Duc Minh Hoang, PhD

  Vinmec Research Institute of Stem Cell and Gene Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 16, 2020
• Study Start: June 9, 2020
• Primary Completion: July 30, 2021
• Study Completion: December 25, 2022
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)