Condition category
Signs and Symptoms
Date applied
17/08/2017
Date assigned
23/08/2017
Last edited
21/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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?
July 2017 to December 2019

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

Trial website

Contact information

Type

Public

Primary contact

Prof Hon-Kan Yip

ORCID ID

Contact details

No. 123
Ta Pei Road Niao Sung District
Kaohsiung
83301
Taiwan
+886 (0)7 731 7123 ext. 8300
han.gung@msa.hinet.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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

Chang Gung Memorial Hospital, 16/04/2017, ref: 106-2457C

Study design

Prospective single-center interventional trial

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 to request a patient information sheet

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 106 cells/kg (n=3)
2. 5.0 x 106 cells/kg (n=3)
3. 1.0 x 107 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

Phase

Drug names

Primary outcome measures

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 trial start date

27/07/2017

Overall trial end date

14/12/2019

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

20 patients (10 patients with ARDS and the other 10 patients with septic shock and multiple organ failure)

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

14/12/2019

Locations

Countries of recruitment

Taiwan

Trial participating centre

Kaohsiung Chang Gung Memorial Hospital
No.123, Ta Pei Road, Niao Sung District
Kaohsiung
83301
Taiwan

Sponsor information

Organisation

Chang Gung Memorial Hospital, Chang Gung Medical Foundation

Sponsor details

No.5
Fuxing St.
Guishan Dist.
Taoyuan
33305
Taiwan
+886 (0)7 731 7123
mellee@cgmh.org.tw

Sponsor type

Hospital/treatment centre

Website

https://www.cgmh.org.tw

Funders

Funder type

Research organisation

Funder name

Chang Gung Medical Research Program Grant (grant no.: CMRPG8E1241)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trialists plan to report this trial results in a scientific journal in the future.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

14/12/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes