COPDPhase 1/2NCT04433104
Umbilical Cord Mesenchymal Stem Cells Transplantation in the Treatment of Chronic Obstructive Pulmonary Disease
A Phase 1/2 study testing Umbilical Cord Mesenchymal Stem Cells transplantation and drug therapy according to Vietnamese MOHS procedure in people with COPD, run by Vinmec Research Institute of Stem Cell and Gene Technology at 1 site in Vietnam.
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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- COPD
- What is being tested?
- Umbilical Cord Mesenchymal Stem Cells transplantation and drug therapy according to Vietnamese MOHS procedure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteVietnam
- Study dates
- 9 Jun 2020to 25 Dec 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with COPD with stage B, C, or D according to GOLD 2019.
- Age between 40-75 years old.
- Both genders.
Who cannot join
- 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.
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- 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%
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Being tested
- Umbilical Cord Mesenchymal Stem Cells transplantation, drug therapy according to Vietnamese MOHS procedure
- Keywords
- COPD, umbilical cord mesenchymal stem cells
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord Mesenchymal Stem Cells transplantationBiological
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 procedureDrug
Salbutamol, Terbutaline
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: drug therapy according to Vietnamese MOHS procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to the 12-month period following treatment
Secondary outcomes (19)
Quality of Life using Georges Respiratory Questionnaire
Georges Respiratory Questionnaire has scores range from 0 to 100, with higher scores indicating more limitations
Measured: up to the 12-month period following treatment
Chest CT
Changes of the lung fibrosis on chest CT at 6 months, and 12 months compared with baseline
Measured: up to the 12-month period following treatment
arterial blood gas analysis (pH)
arterial blood gas analysis (pH)
Measured: up to the 12-month period following treatment
arterial blood gas analysis (PaO2)
arterial blood gas analysis (PaO2)
Measured: up to the 12-month period following treatment
arterial blood gas analysis (PaCO2)
arterial blood gas analysis (PaCO2)
Measured: up to the 12-month period following treatment
arterial blood gas analysis (BE)
arterial blood gas analysis (BE)
Measured: up to the 12-month period following treatment
arterial blood gas analysis (HCO3-)
arterial blood gas analysis (HCO3-)
Measured: up to the 12-month period following treatment
Respiratory functions (FEV1)
Respiratory functions (FEV1)
Measured: up to the 12-month period following treatment
Respiratory functions (FEV1/FVC)
Respiratory functions (FEV1/FVC)
Measured: up to the 12-month period following treatment
Respiratory functions (VC)
Respiratory functions (VC)
Measured: up to the 12-month period following treatment
Respiratory functions (TLC)
Respiratory functions (TLC)
Measured: up to the 12-month period following treatment
Respiratory functions (RV)
Respiratory functions (RV)
Measured: up to the 12-month period following treatment
Respiratory functions (DLCO)
Respiratory functions (DLCO)
Measured: up to the 12-month period following treatment
Respiratory functions (DLNO/DLCO)
Respiratory functions (DLNO/DLCO)
Measured: up to the 12-month period following treatment
inflammatory response (CRP)
inflammatory response (CRP)
Measured: up to the 12-month period following treatment
inflammatory response (Pro-BNP)
inflammatory response (Pro-BNP)
Measured: up to the 12-month period following treatment
inflammatory response (Troponin-T)
inflammatory response (Troponin-T)
Measured: up to the 12-month period following treatment
cytokine analysis from patients' plasma
cytokine analysis from patients' plasma
Measured: up to the 12-month period following treatment
modified medical research council
modified medical research council (mMRC)
Measured: up to the 12-month period following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start9 Jun 2020
- Primary completion30 Jul 2021
- Study completion25 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duc Minh Hoang, PhD, Principal investigator, Vinmec Research Institute of Stem Cell and Gene Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433104
- Sponsor's protocol ID
- VinmecISC1916
- Status last verified
- Jun 2024
- First submitted
- 9 Jun 2020
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21311694Stessuk 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.
PubMed 24255620Stolk 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.
PubMed 26819296Hoang 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.
PubMed 33986057
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04433104
- Acronym / sponsor ID
- VinmecISC1916
- Conditions
- COPD
- Keywords
- COPD, umbilical cord mesenchymal stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vinmec Research Institute of Stem Cell and Gene TechnologyUniversity, hospital or other
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 25 Dec 2022 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment (UC-MSC trasnplatation) | Experimental | Biological: Umbilical Cord Mesenchymal Stem Cells transplantation, Drug: drug therapy according to Vietnamese MOHS procedure1 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: drug therapy according to Vietnamese MOHS proceduredrug therapy according to Vietnamese MOHS procedure |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with COPD with stage B, C, or D according to GOLD 2019.
- Age between 40-75 years old.
- Both genders.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical Cord Mesenchymal Stem Cells transplantationPatients 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 | Biological | Treatment (UC-MSC trasnplatation) |
| drug therapy according to Vietnamese MOHS procedureSalbutamol, Terbutaline | Drug | Treatment (UC-MSC trasnplatation), control arm |
Primary outcome
Adverse events and serious adverse events
Time frame: up to the 12-month period following treatment
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
19 secondary outcomes
Quality of Life using Georges Respiratory Questionnaire
Time frame: up to the 12-month period following treatment
Chest CT
Time frame: up to the 12-month period following treatment
arterial blood gas analysis (pH)
Time frame: up to the 12-month period following treatment
arterial blood gas analysis (PaO2)
Time frame: up to the 12-month period following treatment
arterial blood gas analysis (PaCO2)
Time frame: up to the 12-month period following treatment
arterial blood gas analysis (BE)
Time frame: up to the 12-month period following treatment
arterial blood gas analysis (HCO3-)
Time frame: up to the 12-month period following treatment
Respiratory functions (FEV1)
Time frame: up to the 12-month period following treatment
Respiratory functions (FEV1/FVC)
Time frame: up to the 12-month period following treatment
Respiratory functions (VC)
Time frame: up to the 12-month period following treatment
Respiratory functions (TLC)
Time frame: up to the 12-month period following treatment
Respiratory functions (RV)
Time frame: up to the 12-month period following treatment
Respiratory functions (DLCO)
Time frame: up to the 12-month period following treatment
Respiratory functions (DLNO/DLCO)
Time frame: up to the 12-month period following treatment
inflammatory response (CRP)
Time frame: up to the 12-month period following treatment
inflammatory response (Pro-BNP)
Time frame: up to the 12-month period following treatment
inflammatory response (Troponin-T)
Time frame: up to the 12-month period following treatment
cytokine analysis from patients' plasma
Time frame: up to the 12-month period following treatment
modified medical research council
Time frame: up to the 12-month period following treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Results publication: PubMed 21311694Ribeiro-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.
- Results publication: PubMed 24255620Stessuk 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.
- Results publication: PubMed 26819296Stolk 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.
- Derived from this study: PubMed 33986057Hoang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duc Minh Hoang, PhD principal investigator
Vinmec Research Institute of Stem Cell and Gene Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Umbilical Cord Mesenchymal Stem Cells transplantation and drug therapy according to Vietnamese MOHS procedure in people with COPD, run by Vinmec Research Institute of Stem Cell and Gene Technology at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events and serious adverse events (time frame: up to the 12-month period following treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04433104, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.