Acute Kidney InjuryPhase 1/2NCT04194671
Clinical Trial of Mesenchymal Stem Cells in the Treatment of Severe Acute Kidney Injury
A Phase 1/2 study testing Mesenchymal stem cells and Saline in people with Acute Kidney Injury and Mesenchymal Stem Cells, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Acute kidney injury(AKI) is a common, severe emergency case in clinics,especially severe AKI ,which is associated with higher morbidity and mortality. Effect of routine therapy is limited and mesenchymal stem cells (MSC)are considered a new therapy for treating severe acute kidney injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Kidney Injury, Mesenchymal Stem Cells
- What is being tested?
- Mesenchymal stem cells and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2021to 31 Dec 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have severe AKI defined as more than two-fold increase serum creatinine level compared with baseline within 48 hours and/or urinary output consistently<0.5 ml/kg/h over 12 hours
- Age between 18 and 65 years
- Willing or having a legally acceptable representative to give a written informed consent
- Able to comply with visit schedule and study procedures including post-hospitalization discharge follow-up
Who cannot join
- AKI due to post-renal outflow obstruction,glomerulonephritis,lupus nephritis, antineutrophil cytoplasmic antibody (ANCA) related nephritis, antiglomerular basement membrane disease, cryoglobulinemia, thrombotic microangiopathy, and AKI caused by purpura nephritis
- Pregnant or lactating woman
- Allergic person
- Organ transplant or hematopoietic stem cell transplant
- Patients with malignant tumors or those with a history of cancer
- Life expectancy is less than 3 months
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- Known end-stage liver disease
- Uncontrollable infection
- Patients younger than 65 years old ,whose estimated glomerular filtration rate (eGFR) were less than 60
- Severe pulmonary dysfunction
- Severe cardiac dysfunction,left ventricular ejection fraction is less than 40%, or severe arrhythmia patients
- Hemodynamically unstable patients
- Organ failure affecting more than 2 non-renal organs
- Acute or chronic vasculitis of any cause
- History of chronic systemic infection of any cause
- The investigators believe that subjects may need to gradually increase the dose of vasopressor to achieve and / or maintain hemodynamic stability
- Systemic immunosuppressive therapy that has not been stabilized for greater than 4 months, or in the case of chronic corticosteroid therapy, a dose of >15 mg/day of prednisone or the equivalent within the past 30 days
- Platelet count <25,000/uL or other severe hematologic abnormalities, causing the subject to be at risk of death
- Patients need mechanical ventilation
- Participate in other clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Placebo-controlled, Patient-blinded Study of Mesenchymal Stem Cells Therapy in Subjects With Severe Acute Kidney Injury Receiving Routine Therapy
Acute kidney injury(AKI) is a common, severe emergency case in clinics,especially severe AKI ,which is associated with higher morbidity and mortality. Effect of routine therapy is limited and mesenchymal stem cells (MSC)are considered a new therapy for treating severe acute kidney injury. Patients will be randomized to receive intravenous infusion of MSC, or placebo control. This trial is to investigate whether MSC can improve renal recovery and mortality of patients with AKI.
- Conditions
- Acute Kidney Injury, Mesenchymal Stem Cells
- Being tested
- Mesenchymal stem cells, Saline
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cellsBiological
In experimental group, patients receive standard treatment and allogeneic human umbilical cord derived-mesenchymal stem cells (MSCs) is administered via intravenous infusion on day 0 and day 7
SalineOther
In placebo control group, patients receive standard treatment and saline is administered via intravenous infusion on day 0 and day 7
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cells cohort | Experimental | Not described Receives: Biological: Mesenchymal stem cells |
| Saline cohort | Placebo comparator | Not described Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the renal function between the two groups (MSC treatment group vs placebo control group) within 28 days after receiving MSC/ placebo treatment
Compare the creatinine concentration between the two groups (MSC treatment group vs placebo control group) at 28 days after receiving MSC/ placebo treatment.
Measured: within 28 days after receiving MSC/ placebo treatment
Secondary outcomes (7)
Overall survival within 28 days after receiving MSC/ placebo treatment
Compare the overall survival rate between the two groups (MSC treatment group vs placebo control group) at 28 days after receiving MSC/ placebo treatment.
Measured: 28 days
Overall survival within 3 months after receiving MSC/ placebo treatment
Compare the overall survival rate between the two groups (MSC treatment group vs placebo control group) at month 3 after receiving MSC/ placebo treatment.
Measured: 3 months
Renal replacement therapy (RRT) dependent within 3 months after receiving MSC/ placebo treatment
Compare the rate of renal replacement therapy (RRT) dependence between the two groups (MSC treatment group vs placebo control group) at month 3 after receiving MSC/ placebo treatment.
Measured: 3 months
Complete renal recovery within 3 months after receiving MSC/ placebo treatment
Compare the rate of complete renal recovery between the two groups (MSC treatment group vs placebo control group) at month 3 after receiving MSC/placebo treatment. We considered complete recovery as alive, free of RRT, and the SCR decreased to no more than 1.5 times of the baseline level.
Measured: 3 months
Partial renal recovery within 3 months after receiving MSC/ placebo treatment
Compare the rate of partial renal recovery between the two groups (MSC treatment group vs placebo control group) at month 3 after receiving MSC/placebo treatment. Partial recovery refers to survival, free of RRT, and the SCR 1.5 times higher than the baseline level of creatinine.
Measured: 3 months
ICU and hospitalization duration of stay among all AKI patients within 3 months after receiving MSC/ placebo treatment
Compare the days in ICU and hospital between the two groups (MSC treatment group vs placebo control group) at month 3 after receiving MSC/placebo treatment.
Measured: 3 months
Adverse events within 3 months after receiving MSC/ placebo treatment
Compare the rate of adverse events between the two groups (MSC treatment group vs placebo control group) at month 3 after receiving MSC/placebo treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start31 Dec 2021 (estimated)
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Xiangmei, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194671
- Sponsor's protocol ID
- MSC-001
- Status last verified
- Oct 2021
- First submitted
- 9 Dec 2019
- Last updated
- 25 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Yang Y, Gao J, Wang S, Wang W, Zhu FL, Wang X, Liang S, Feng Z, Lin S, Zhang L, Chen X, Cai G. Efficacy of umbilical cord mesenchymal stem cell transfusion for the treatment of severe AKI: a protocol for a randomised controlled trial. BMJ Open. 2022 Feb 21;12(2):e047622. doi: 10.1136/bmjopen-2020-047622.
PubMed 35190406
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Placebo-controlled, Patient-blinded Study of Mesenchymal Stem Cells Therapy in Subjects With Severe Acute Kidney Injury Receiving Routine Therapy
- ClinicalTrials.gov ID
- NCT04194671
- Acronym / sponsor ID
- MSC-001
- Conditions
- Acute Kidney Injury, Mesenchymal Stem Cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 31 Dec 2021 (estimated)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute kidney injury(AKI) is a common, severe emergency case in clinics,especially severe AKI ,which is associated with higher morbidity and mortality. Effect of routine therapy is limited and mesenchymal stem cells (MSC)are considered a new therapy for treating severe acute kidney injury. Patients will be randomized to receive intravenous infusion of MSC, or placebo control. This trial is to investigate whether MSC can improve renal recovery and mortality of patients with AKI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cells cohort | Experimental | Biological: Mesenchymal stem cells |
| Saline cohort | Placebo comparator | Other: Saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have severe AKI defined as more than two-fold increase serum creatinine level compared with baseline within 48 hours and/or urinary output consistently<0.5 ml/kg/h over 12 hours
- Age between 18 and 65 years
- Willing or having a legally acceptable representative to give a written informed consent
- Able to comply with visit schedule and study procedures including post-hospitalization discharge follow-up
Key exclusion criteria (20 listed)
- AKI due to post-renal outflow obstruction,glomerulonephritis,lupus nephritis, antineutrophil cytoplasmic antibody (ANCA) related nephritis, antiglomerular basement membrane disease, cryoglobulinemia, thrombotic microangiopathy, and AKI caused by purpura nephritis
- Pregnant or lactating woman
- Allergic person
- Organ transplant or hematopoietic stem cell transplant
- Patients with malignant tumors or those with a history of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal stem cellsIn experimental group, patients receive standard treatment and allogeneic human umbilical cord derived-mesenchymal stem cells (MSCs) is administered via intravenous infusion on day 0 and day 7 | Biological | Mesenchymal stem cells cohort |
| SalineIn placebo control group, patients receive standard treatment and saline is administered via intravenous infusion on day 0 and day 7 | Other | Saline cohort |
Primary outcome
The difference in the renal function between the two groups (MSC treatment group vs placebo control group) within 28 days after receiving MSC/ placebo treatment
Time frame: within 28 days after receiving MSC/ placebo treatment
Compare the creatinine concentration between the two groups (MSC treatment group vs placebo control group) at 28 days after receiving MSC/ placebo treatment.
7 secondary outcomes
Overall survival within 28 days after receiving MSC/ placebo treatment
Time frame: 28 days
Overall survival within 3 months after receiving MSC/ placebo treatment
Time frame: 3 months
Renal replacement therapy (RRT) dependent within 3 months after receiving MSC/ placebo treatment
Time frame: 3 months
Complete renal recovery within 3 months after receiving MSC/ placebo treatment
Time frame: 3 months
Partial renal recovery within 3 months after receiving MSC/ placebo treatment
Time frame: 3 months
ICU and hospitalization duration of stay among all AKI patients within 3 months after receiving MSC/ placebo treatment
Time frame: 3 months
Adverse events within 3 months after receiving MSC/ placebo treatment
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Derived from this study: PubMed 35190406Yang Y, Gao J, Wang S, Wang W, Zhu FL, Wang X, Liang S, Feng Z, Lin S, Zhang L, Chen X, Cai G. Efficacy of umbilical cord mesenchymal stem cell transfusion for the treatment of severe AKI: a protocol for a randomised controlled trial. BMJ Open. 2022 Feb 21;12(2):e047622. doi: 10.1136/bmjopen-2020-047622.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mesenchymal stem cells and Saline in people with Acute Kidney Injury and Mesenchymal Stem Cells, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the renal function between the two groups (MSC treatment group vs placebo control group) within 28 days after receiving MSC/ placebo treatment (time frame: within 28 days after receiving MSC/ placebo treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04194671, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.