Stem cell transplantation for chronic obstructive pulmonary disease treatment
| ISRCTN | ISRCTN70443938 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70443938 |
| Secondary identifying numbers | 082/2017/QD-NCKH |
- Submission date
- 06/07/2019
- Registration date
- 16/10/2019
- Last edited
- 17/02/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
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
Contact information
Public
Van Hanh General Hospital
District 10
Ho Chi Minh
084
Viet Nam
| Phone | +84 (0)961828236 |
|---|---|
| phuongltb@benhvienvanhanh.com |
Public
Ho Chi Minh City University of Science
227 Đường Nguyễn Văn Cừ
Phường 4
Quận 5
Hồ Chí Minh
-
Viet Nam
 ORCID ID |
0000-0001-7254-0717 |
|---|---|
| phucpham@sci.edu.vn |
Study information
| Study design | Interventional non-randomised parallel assignment single masking (participant) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Umbilical cord-derived mesenchymal stem cell transplantation for chronic obstructive pulmonary disease treatment: a phase II clinical trial |
| Study 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(s) | 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. |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | 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 study start date | 12/12/2017 |
| Overall study end date | 05/05/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 20 |
| Total final enrolment | 20 |
| 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 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
Study participating centre
Phường 12
Quận 10
Ho Chi Minh
084
Viet Nam
Sponsor information
Research organisation
Stem Cell Institute
B23 Building, University of Science
Ward 6, Thu Duc District, Ho Chi Minh City
Ho Chi Minh City
084
Viet Nam
| Phone | +842836361206 |
|---|---|
| contact@sci.edu.vn | |
| Website | www.vientebaogoc.edu.vn |
"ROR" |
https://ror.org/00waaqh38 |
Funders
Funder type
Research organisation
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/02/2020 | 17/02/2020 | Yes | No |
Editorial Notes
17/02/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
16/10/2019: Trial’s existence confirmed by the Van Hanh General Hospital Ethical Committee
