Human stem cell therapy for acute respiratory distress syndrome
| ISRCTN | ISRCTN47911040 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47911040 |
| Secondary identifying numbers | 2021/03/08 ver1.5, Grant No.: NMRPG8L6151, NMRPG8L6152, NMRPG8L6153 |
- Submission date
- 17/09/2021
- Registration date
- 26/10/2021
- Last edited
- 08/01/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Acute respiratory distress syndrome (ARDS) is a life-threatening lung injury that allows fluid to leak into the lungs. Breathing becomes difficult and oxygen cannot get into the body. Most people who get ARDS are already at the hospital for trauma or illness.
ARDS, frequently complicated with multiple-organ failure, undoubtedly causes an unacceptably high in-hospital death rate. Although the causes and underlying mechanisms of ARDS have been extensively studied, effective treatment is still limited. Therefore, it is urgent and important to develop a safe and effective treatment for ARDS. Many studies have shown that mesenchymal stem cells (MSCs) effectively improve inflammatory reactions and reduce immune responses. A recent trial showed that human umbilical cord-derived mesenchymal stem cells (HUCDMSCs) are safe with a better clinical outcome in moderate to severe ARDS patients. The aim of this study is to measure the effectiveness of injection of HUCDMSCs in moderate to severe ARDS patients.
Who can participate?
Adult patients aged 20-80 years with moderate to severe ARDS whose symptoms don’t improve 5 days after traditional or standard therapy
What does the study involve?
Participants are randomly allocated into a high-dose treatment group, a low-dose treatment group and a control group. In the low-dose treatment group, participants will be given a high dose of HUCDMSCs two times 72 hours apart. In the high-dose treatment group, participants will be given a low dose of HUCDMSCs two times 72 hours apart. The control group receive only the HUCDMSCs transfer medium two times 72 hours apart.
What are the possible benefits and risks of participating?
The possible benefits include a decrease in death rate, no safety issues, and tolerance of stem cell treatment. The risks include thromboembolic events (blood clots in the veins) during cell delivery, arrhythmia (heart rhythm problems), or any one of exacerbated following complications resulted from pre-existing ARDS, e.g., anemia, hemorrhage, kidney function deterioration, or electrolyte imbalance.
Where is the study run from?
Kaohsiung Chang Gung Memorial Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
March 2020 to December 2027
Who is funding the study?
Chang Gung Memorial Hospital, Chang Gung Medical Foundation (Taiwan)
Who is the main contact?
Hon-Kan Yip, MD
han.gung@msa.hinet.net
Contact information
Public
No. 123, Dapi Rd.
Niaosong Dist.
Kaohsiung
83301
Taiwan
 ORCID ID |
0000-0002-6305-5717 |
|---|---|
| Phone | +886 (0)7 7317123 ext. 8300 |
| han.gung@msa.hinet.net |
Study information
| Study design | Prospective single-center interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Application of human umbilical cord-derived mesenchymal stem cells for moderate to severe acute respiratory distress syndrome: a randomized phase II clinical trial |
| Study objectives | Human umbilical cord-derived mesenchymal stem cells (HUCDMSCs) may be a therapeutic option for patients with moderate to severe acute respiratory distress syndrome (ARDS) |
| Ethics approval(s) | Approved 14/04/2021, Chang Gung Medical Foundation Institutional Review Board (199, Tunghua North. Road., Songshan Dist., Taiperi, 15057, Taiwan; +886 (0)3 3196200#3708; troublefup6@cgmh.org.tw), ref: 202000098A0 |
| Health condition(s) or problem(s) studied | Moderate to severe acute respiratory distress syndrome |
| Intervention | Randomization process The study sequence will be generated by a computerized random number generator and preserved in a sealed envelope. The envelopes will be opened in consecutive order for enrollment prior to stem cell infusion therapy by research nurses who are blinded to case randomization. This clinical trial will enroll 60 patients within 3 years and the patients will be categorized into a high-dose treatment group (n=20), a low-dose treatment group (n=20) and a control group (n=20) by a randomized double-blinded, placebo-controlled method. In the low-dose treatment group, patients will be administered the HUCDMSCs twice (6.5 x 10^5/kg/each time, time interval 72h). In the high-dose treatment group, patients will be administered HUCDMSCs twice (6.5 x 10^6/kg/each time, time interval 72 h). The control group will receive only transfer medium twice (1.625 ml/kg/each time, time interval 72 h). The cells or transfer medium will be administered by intravenous injection. Total duration of treatment: 4 days Follow-up for all study arms: 1 year |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Human umbilical cord-derived mesenchymal stem cells (HUCDMSCs) |
| Primary outcome measure | The in-hospital mortality and 30-day mortality recorded according to medical charts |
| Secondary outcome measures | 1. Severity of ARDS measured using APCHE II (Acute Physiology and Chronic Health Evaluation) score during hospitalization 2. Organ function assessed using Sequential Organ Failure Assessment (SOFA) with parameters of GCS level, PaO₂/FiO₂, vital signs, level of serum creatinine, alanine aminotransferase (ALT), total bilirubin, prothrombin time (PT), activated partial thromboplastin time (aPTT), platelet count, C-reactive protein (CRP), and lactate at baseline (pre-infusion), day 1, 3, 7 post-infusion, and 1-month post-infusion 3. Adverse events of stem cell transplantation including immune response, hyperreactivity, anaphylactic shock, incidental malignancy recorded using pulmonary X-ray or other imaging systems at 12 months post-infusion |
| Overall study start date | 14/03/2020 |
| Completion date | 31/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Adult subjects aged 20-80 years with moderate to severe ARDS, defined as: 1.1. Acute onset 1.2. Bilateral infiltration on chest X-ray 1.3. Pulmonary wedge pressure ≤18 mmHg 1.4. PaO₂/FiO₂ ≤200 mmHg 1.5. PEEP ≥10 cm H₂O 2. Symptoms don’t improve 5 days after traditional or standard therapy |
| Key exclusion criteria | 1. Age <20 or >80 years 2. Pregnancy, breastfeeding 3. Malignancy 4. Autoimmune disease 5. Subjects not suitable for enrollment due to any reason evaluated by the investigator, or patients who have joined other studies |
| Date of first enrolment | 16/04/2020 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Niaosong Dist.
Kaohsiung
83301
Taiwan
Sponsor information
Hospital/treatment centre
Chang Gung Medical Foundation
No. 5, Fuxing St.
Guishan Dist.
Taoyuan
33305
Taiwan
| Phone | +886 (0)3 3184301 |
|---|---|
| isc@cgmh.org.tw | |
| Website | https://www.cgmh.org.tw |
"ROR" |
https://ror.org/02verss31 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Chia-Yi Chang-Gong Memorial Hospital, Chang Gung Memorial Hospital, Chia-Yi
- Location
- Taiwan
Results and Publications
| Intention to publish date | 31/12/2029 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
08/01/2025: The following changes were made:
1. The overall study end date was changed from 31/12/2025 to 31/12/2027.
2. Phase II added.
3. Biological name added.
4. The recruitment end date was changed from 31/12/2024 to 31/12/2026.
27/09/2021: Trial's existence confirmed by the Chang Gung Medical Foundation Institutional Review Board.
