Condition category
Respiratory
Date applied
06/07/2019
Date assigned
16/10/2019
Last edited
16/10/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death overall. The main mechanism of COPD related to inflammation and its magnification in the lung and whole body. The current treatments including oxygen therapy, medications and physical therapy have limitations, especially in end-stage COPD.
Transplantation of mesenchymal stem cells (MSCs) maybe is an effective approach to treat COPD due to their immunomodulation property.
In this study, we aimed to evaluate the safety and efficacy of umbilical cord derived expanded mesenchymal stem cells transplantation in COPD treatment

Who can participate?
Stage C and D COPD patients

What does the study involve?
All participants were intravenously infused with qualified umbilical cord-derived stem cell with a dose of 1.5 million cells per kg and followed up for 6 months

What are the possible benefits and risks of participating?
Participants can receive the new method for treating COPD which is proved the safety and effectiveness in vitro and in vivo. The new method might help patients to control the disease and improve their quality of life.
Participants might have some side effects during the stem cell-based treatment. They are high fever, dyspnea, arrhythmias, creatinine increase, headache, sleep disorder. However, such symptoms are transient and relieve without any specific intervention

Where is the study run from?
1. Van Hanh General Hospital, Viet Nam
2. Vietnam Military Academy 103, Viet Nam

When is the study starting and how long is it expected to run for?
December 2019 to December 2019

Who is funding the study?
The Ministry of Science and Technology, Viet Nam

Who is the main contact?
1. Dr Phuc Van Pham,
phucpham@sci.edu.vn
2. Dr Phuong Le Thi Bich,
phuongltb@benhvienvanhanh.com

Trial website

Contact information

Type

Public

Primary contact

Dr Phuong Le Thi Bich

ORCID ID

Contact details

Van Hanh General Hospital
District 10
Ho Chi Minh
084
Viet Nam
+84 (0)961828236
phuongltb@benhvienvanhanh.com

Type

Public

Additional contact

Dr Phuc Van Pham

ORCID ID

https://orcid.org/0000-0001-7254-0717

Contact details

Ho Chi Minh City University of Science
227 Đường Nguyễn Văn Cừ
Phường 4
Quận 5
Hồ Chí Minh
-
Viet Nam
-
phucpham@sci.edu.vn

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

082/2017/QD-NCKH

Study information

Scientific title

Umbilical cord-derived mesenchymal stem cell transplantation for chronic obstructive pulmonary disease treatment: a phase II clinical trial

Acronym

UCMSC-COPD

Study hypothesis

Umbilical cord-derived mesenchymal stem cells strongly display immune modulation potential compared to other kinds of mesenchymal stem cells that were isolated from other sources. Recent studies showed that adipose tissues and bone marrow-derived mesenchymal stem cell allogenic transplantation is safe and gives positive effects on the chronic obstructive pulmonary disease (COPD). However, there are not any clinical trials to evaluate the safety and efficacy of umbilical cord-derived mesenchymal stem cell transplantation for COPD treatment.

This study aimed to evaluate the safety and efficacy of allogeneic umbilical cord-derived mesenchymal stem cell transplantation for COPD patients.

We hypothesize that allogenic umbilical cord-derived mesenchymal stem cell transplantation is the promising method to treat COPD.

Ethics approval

Approved 28/09/2017, the Van Hanh General Hospital Ethical Committee (781/B1-B3-B5 Hẻm 781 Lê Hồng Phong, Ward 12, District 10, Ho Chi Minh city, Viet Nam; Nghiencuukhoahoc@benhvienvanhanh.com; +84 2838632553), ref: 082/2017/QD-NCKH.

Study design

Interventional non-randomised parallel assignment single masking (participant)

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic obstructive pulmonary disease (CODD) stage III and IV

Intervention

Patients were infused with 1-2 million cells of allogeneic in vitro expanded mesenchymal stem cells derived from umbilical cord tissues per kg body weight.

The umbilical cord was collected from the donor with consent forms. The mesenchymal stem cells from umbilical cord tissue were isolated and expanded in vitro using the UC-SCI technology (from Stem Cell Institute, VNUHCM University of Science, HCMC, Viet Nam). The umbilical cord-derived mesenchymal stem cell manufacturing procedure is compliant with good manufacturing practices (GMP).

All patients were followed-up for 24 at the hospital after transfusion; then followed-up up to 6 months

Intervention type

Biological/Vaccine

Phase

Phase II

Drug names

Off-the-shelf human allogenic umbilical cord-derived mesenchymal stem cells

Primary outcome measure

Improvement in pulmonary function determined by the incidence, frequency and/or severity of adverse events over 6 months after treatment compared to the same before treatment using patient notes

Secondary outcome measures

1. Respiratory function was measured by medical test to determine a change in FEV1 during 6 months of follow-up of stem cell transplantation
2. Exercise capability was measured by medical test to determine a change in 6-minute walking test during 6 months of follow-up after stem cell treatment
3. The degree of dyspnea was assessed by questionnaires to determine the mMRC and CAT scales before and 1month, 3 months, 6 months after stem cell treatment
4. The improvement of inflammatory response was measured by medical test to determine CRP concentration in the body before and 1month, 3 months, 6 months after stem cell treatment

Overall trial start date

12/12/2017

Overall trial end date

05/05/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Diagnosed with COPD stage C and D in accordance with GOLD 2016
2. Aged between 40 and 80 years old
3. Understand and agree to the written consent form

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

20

Participant exclusion criteria

1. Current smoker or smoking cessation with the time of cessation less than 6 months;
2. Asthma or clinically relevant lung diseases other than COPD (lung tuberculosis, restrictive lung disease, idiopathic pulmonary fibrosis, lung cancer)
3. Active infection requiring antibiotic therapy
4. Active Mycobacterium infection
5. Clinically relevant not associated with COPD during screening: Left ventricle ejection fraction lower than 40%, valvular heart disease, cardiomyopathy disease, arrhythmia, congenital heart disease, kidney failure with Creatinine index > 2.0 mg/dl, liver disease with AST, ALT or bilirubin 2 times more than upper limit of normal range, haematological disorder or cancer
6. Using TNF inhibitor within 3 months prior to the screening visit
7. Using an immunosuppressive medicine 8 weeks prior to the screening visit
8. Active malignancy or history of cancer without recurrence within 5 years prior to the screening visit
9. Taking part in other clinical trials with any medicine or medical device
10. Unable to perform all of the assessments required for the study.

Recruitment start date

05/05/2018

Recruitment end date

05/05/2019

Locations

Countries of recruitment

Viet Nam

Trial participating centre

Van Hanh General Hospital
781/B1-B3-B5 Hẻm 781 Lê Hồng Phong Phường 12 Quận 10
Ho Chi Minh
084
Viet Nam

Sponsor information

Organisation

Stem Cell Institute, VNUHCM University of Science, Ho Chi Minh city, Viet Nam

Sponsor details

Stem Cell Institute
B23 Building
University of Science
Ward 6
Thu Duc District
Ho Chi Minh City
Ho Chi Minh City
084
Viet Nam
+842836361206
contact@sci.edu.vn

Sponsor type

Research organisation

Website

www.vientebaogoc.edu.vn

Funders

Funder type

Research organisation

Funder name

Stem Cell Institute (VNUHCM University of Science, Viet Nam)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Van Hanh General Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Intention to publish date

31/12/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

16/10/2019: Trial’s existence confirmed by the Van Hanh General Hospital Ethical Committee