Application of human umbilical cord-derived mesenchymal stem cells for patients with severe acute respiratory distress syndrome and/or profound septic shock complicated with multiple organ failure
| ISRCTN | ISRCTN52319075 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52319075 |
| Secondary identifying numbers | N/A |
- Submission date
- 17/08/2017
- Registration date
- 23/08/2017
- Last edited
- 08/01/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Signs and Symptoms
Plain English Summary
Background and study aims
Many acutely ill patients are killed by severe acute respiratory distress syndrome (ARDS) and septic shock complicated with multiple organ failure. ARDS is a condition where the lungs can't provide the body's vital organs with enough oxygen. The causes of ARDS include infection, severe shock, trauma, aspiration injury, or severe systemic inflammation. Septic shock is when blood pressure drops to a dangerously low level after an infection. Many people eventually die of loss of multiple organ function. Even with prompt and proper antibiotic treatment, the death rate is quite high. It is important to find a new method to improve survival rates. Stem cells are able to regulate the immune system, are anti-inflammation and have the ability to repair tissues. The aim of this study to test the safety of human umbilical cord-derived mesenchymal stem cells in patients with ARDS and multiple organ failure complicating severe septic shock.
Who can participate?
Patients aged 20-80 with ARDS or severe septic shock, whose symptoms do not improve 5 days after traditional or standard treatment
What does the study involve?
Participants are randomly allocated to be treated with one of three doses of stem cells administered into their veins. The injected number of stem cells is gradually increased if safety is confirmed after injection of the lower dose. Safety is defined as no relevant side effects, such as allergy, immunosuppressant effect, or treatment-associated organ damage or death. The stem cell treatment takes less than 2 hours. After discharge, participants are followed up regularly in the outpatient setting at 1 month and every 3 months. The total follow-up period is one year.
What are the possible benefits and risks of participating?
The possible benefits of stem cell treatment include life-supporting or life-saving effects. The treatment may be used in future to protect organ function in critically ill patients. The relevant risks are irregular heart rhythm, heart attack, heart failure, brain ischemia, bleeding, anemia, worsening kidney function, electrolyte imbalance, malignancy, and so on. However, the reported rate of the above side effects is less than 1%.
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?
December 2015 to November 2027
Who is funding the study?
Chang Gung Medical Research Program Grant (Taiwan)
Who is the main contact?
Prof. Hon-Kan Yip
han.gung@msa.hinet.net
Contact information
Public
No. 123, Ta Pei Road Niao Sung District
Kaohsiung
83301
Taiwan
| Phone | +886 (0)7 731 7123 ext. 8300 |
|---|---|
| han.gung@msa.hinet.net |
Study information
| Study design | Prospective single-center interventional trial |
|---|---|
| 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 to request a patient information sheet |
| Scientific title | Application of human umbilical cord-derived mesenchymal stem cells for patients with severe acute respiratory distress syndrome and/or profound septic shock complicated with multiple organ failure: a phase I clinical trial for evaluation of safety and tolerability |
| Study acronym | HUCDMSC for patients with severe ARDS and/or septic shock |
| Study hypothesis | Human umbilical cord-derived mesenchymal stem cells (HUCDMSC) may be a therapeutic option for patients with ARDS and profound septic shock complicated with multiple organ failure. |
| Ethics approval(s) | Chang Gung Memorial Hospital, 16/04/2017, ref: 106-2457C |
| Condition | Acute respiratory distress syndrome and/or profound septic shock complicated with multiple organ failure |
| Intervention | The eligible subjects who are willing to receive intravenous therapy with human umbilical cord-derived mesenchymal stem cells for ARDS and profound septic shock complicated with multiple organ failure will be enrolled into this study. Blood biochemistry study will be performed at baseline. Sequentially numbered opaque, sealed envelopes (SNOSE) will be used to allocate the study subjects. Three different dosages of human umbilical cord-derived mesenchymal stem cells will be administered intravenously: 1. 1.0 x 10(6) cells/kg (n=3) 2. 5.0 x 10(6) cells/kg (n=3) 3. 1.0 x 10(7) cells/kg (n=4) The injected number of stem cells will be gradually titrated up if safety is confirmed after injection of the prior lower dose. The safety is defined as no relevant side effects after human umbilical cord-derived mesenchymal stem cell therapy, e.g., allergy, immunosuppressant effect, or therapy-associated organ damage or death. The duration of cell-based treatment with intravenous infusion of stem cells is less than 2 hours. After discharge, patients will be followed up regularly in the outpatient setting at 1 month and every 3 months. The total follow-up period is one year. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | human umbilical cord-derived mesenchymal stem cells |
| Primary outcome measure | 1. Severity of ARDS and septic shock, assessed using APACHE II score at baseline 2. Organ function, assessed daily using SOFA score once daily from enrollment and until freedom from critical condition 3. GCS level, PaO2/FiO2, vital signs, level of serum Cr, ALT, total bilirubin, PT, APTT, platelet count, CRP, and lactate, measured using blood sample once daily from starting treatment 4. In-hospital mortality and 30-day mortality 5. Immune function and cytokine level assessed at baseline, the first 3 days, and one week later |
| Secondary outcome measures | Adverse events including immune response to stem cell therapy, hyperreactivity to HUCDMSC, anaphylactic shock, or incidental malignancy after cell-based therapy. After discharge, patients will be followed up regularly in the outpatient setting at 1 month and every 3 months. The total follow-up period is one year. |
| Overall study start date | 15/12/2015 |
| Overall study end date | 30/11/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 20 patients (10 patients with ARDS and the other 10 patients with septic shock and multiple organ failure) |
| Participant inclusion criteria | 1. Adult subjects aged 20-80 years with severe ARDS or profound septic shock complicated with multiple organ failure due to infection 2. Symptoms do not improve 5 days after traditional or standard therapy 3. Severe acute respiratory distress syndrome defined as acute onset, bilateral infiltration on chest X-ray, pulmonary wedge pressure ≤18 mmHg, and PaO2/FiO2 ≤200 mmHg 4. The definition of profound septic shock complicated with multiple organ failure was systolic blood pressure <90 mmHg with tissue hypoperfusion, combined with at least two organs failure (brain, lung, kidney, liver, or coagulation) |
| Participant exclusion criteria | 1. Age <20 or >80 years 2. Pregnant women 3. Malignancy 4. Autoimmune disease 5. Subjects not suitable for enrollment due to any reason evaluated by investigator 6. Patients who have joined other studies |
| Recruitment start date | 27/07/2017 |
| Recruitment end date | 01/11/2027 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Kaohsiung
83301
Taiwan
Sponsor information
Hospital/treatment centre
No.5, Fuxing St.
Guishan Dist.
Taoyuan
33305
Taiwan
| Phone | +886 (0)7 731 7123 |
|---|---|
| mellee@cgmh.org.tw | |
| Website | https://www.cgmh.org.tw |
"ROR" |
https://ror.org/00k194y12 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 31/12/2028 |
|---|---|
| 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 | The trialists plan to report this trial results in a scientific journal in the future. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | ARDS patients | 01/05/2020 | 21/05/2021 | Yes | No |
Editorial Notes
08/01/2024: The Drug/device/biological/vaccine name(s) was added.
29/12/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2021 to 01/11/2027.
2. The overall trial start date has been changed from 27/07/2017 to 15/12/2015 and the plain English summary updated accordingly.
3. The overall trial end date has been changed from 31/12/2022 to 30/11/2027 and the plain English summary updated accordingly.
4. The intention to publish date has been changed from 31/12/2024 to 31/12/2028.
21/05/2021: Publication reference added.
15/01/2020: The following changes have been made:
1. The recruitment end date has been changed from 14/12/2019 to 31/12/2021.
2. The overall trial end date has been changed from 14/12/2019 to 31/12/2022.
3. The intention to publish date has been changed from 14/12/2020 to 31/12/2024.
05/03/2019: Internal review.
