Kidney TransplantationPhase 1/2NCT02563366
Effect of BM-MSCs on Early Graft Function Recovery After DCD Kidney Transplant.
A Phase 1/2 study testing BM-MSCs and Saline in people with Kidney Transplantation and Acute Kidney Tubular Necrosis, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This study is designed to investigate whether allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs) can promote function recovery in patients with poor early graft function after kidney transplantation from Chinese Donation after Citizen Death (DCD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Transplantation, Acute Kidney Tubular Necrosis
- What is being tested?
- BM-MSCs and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Dec 2017
- 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
- Primary kidney transplantation
- Kidneys are from donation after Chinese citizen death
- Poor early graft function with or without dialysis after transplantation
- Patient is willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months
Who cannot join
- Secondary kidney transplantation
- Combined or multi-organ transplantation
- Women who are pregnant, intend to become pregnant in the next 1 years, breastfeeding, or have a positive pregnancy test on enrollment or prior to study medication administration
- Panel reactive antibody (PRA)>20% or CDC crossmatch is positive
- Donors or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C
- Donors or recipients are known hepatitis B surface antigen-positive or PCR positive for hepatitis B
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- Donors or recipients are known human immunodeficiency virus (HIV) infection
- Patients with active infection
- Recipients with a history of substance abuse (drugs or alcohol) within the past 6 months, or psychotic disorders that are not capable with adequate study follow- up.
- Patients with severe cardiovascular dysfunction
- WBC<3*10^9/L or RBC <5g/dL
- Highly allergic constitution or having severe history of allergies.
- Patients with active peptic ulcer disease, chronic diarrhea, or gastrointestinal problem affect absorption
- Patients with a history of cancer within the last 5 years
- Prisoner or patients compulsorily detained (involuntarily incarcerated) for treatment or either a psychiatric or physical (e.g. infectious disease) illness
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080
Changxi Wang, M.D., Ph.D, 86-20-87333428, wangchx@mail.sysu.edu.cn
Longshan Liu, M.D., Ph.D, 86-20-87306082, liulshan@mail.sysu.edu.cn
About this study
Official title: Effect of Bone Marrow-derived Mesenchymal Stem Cells (BM-MSCs) on Recovery of Poor Early Graft Function Post Kidney Transplantation From Chinese Donation After Citizen Death (DCD): A Multi-center Randomized Controlled Trial
This study is designed to investigate whether allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs) can promote function recovery in patients with poor early graft function after kidney transplantation from Chinese Donation after Citizen Death (DCD). DCD kidney transplant recipients with poor early graft function (with or without dialysis) post transplant are equally randomized into MSCs group or control group. Patients in MSCs group are administered MSCs treatment. Allogeneic BM-MSCs (1*10^6/kg) from third party are given intravenously for four consecutive doses every week after enrollment. Patients in control group receive placebo. Renal allograft function (eGFR), rejection, patient/graft survival and severe adverse events up to 12 months post enrollment are monitored.
- Being tested
- BM-MSCs, Saline
- Keywords
- kidney transplantation, mesenchymal stem cell therapy, poor early graft function, delayed graft function, ischemia reperfusion injury, donation after cardiac death
- Medical subject headings
- Kidney Tubular Necrosis, Acute, Delayed Graft Function, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BM-MSCsOther
Also called allogeneic bone marrow-derived MSCs
BM-MSCs are from third-party healthy volunteer donors.
SalineOther
Saline is the placebo of MSCs in this study.
| Study group | Role | What they receive |
|---|---|---|
| MSCs group | Experimental | Patients with early poor graft function receive allogeneic BM-MSCs at the dose of 1*10^6/kg every week for four consecutive doses. Receives: Other: BM-MSCs |
| Control group | Placebo comparator | Patients with early poor graft function receive placebo of MSCs, i.e. saline every week for four consecutive doses. Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated glomerular filtration rate
eGFR at one month post transplant
Measured: 1 month
Secondary outcomes (6)
Estimated glomerular filtration rate
eGFR up to 12 months post transplant
Measured: 12 months
Proportion of normal renal function recovery
Measured: 12 months
Time to renal function recovery (days)
Measured: 12 months
acute rejection rate
Acute rejection rate according to Banff 2013 criteria up to 12 months post transplant
Measured: 12 months
patient and graft survival rate
patient and graft survival rate up to 12 months post transplantation
Measured: 12 months
Incidence of severe adverse events
Incidence of severe adverse events up to 12 months post transplantation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (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 Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe 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
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Changxi Wang, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Changxi Wang, M.D., Ph.D, Study chair, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563366
- Sponsor's protocol ID
- MSCs-KTx-DCD-150925
- Status last verified
- Sep 2015
- First submitted
- 26 Sep 2015
- Last updated
- 30 Sep 2015
- Results posted
- No
Publications
Peng Y, Ke M, Xu L, Liu L, Chen X, Xia W, Li X, Chen Z, Ma J, Liao D, Li G, Fang J, Pan G, Xiang AP. Donor-derived mesenchymal stem cells combined with low-dose tacrolimus prevent acute rejection after renal transplantation: a clinical pilot study. Transplantation. 2013 Jan 15;95(1):161-8. doi: 10.1097/TP.0b013e3182754c53.
PubMed 23263506
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bone Marrow-derived Mesenchymal Stem Cells (BM-MSCs) on Recovery of Poor Early Graft Function Post Kidney Transplantation From Chinese Donation After Citizen Death (DCD): A Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02563366
- Acronym / sponsor ID
- MSCs-KTx-DCD-150925
- Keywords
- kidney transplantation, mesenchymal stem cell therapy, poor early graft function, delayed graft function, ischemia reperfusion injury, donation after cardiac death
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Guangzhou Medical University
- Study start
- Nov 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 30 Sep 2015 (estimated)
- 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.
This study is designed to investigate whether allogeneic bone marrow-derived mesenchymal stem cells (BM-MSCs) can promote function recovery in patients with poor early graft function after kidney transplantation from Chinese Donation after Citizen Death (DCD). DCD kidney transplant recipients with poor early graft function (with or without dialysis) post transplant are equally randomized into MSCs group or control group. Patients in MSCs group are administered MSCs treatment. Allogeneic BM-MSCs (1*10^6/kg) from third party are given intravenously for four consecutive doses every week after enrollment. Patients in control group receive placebo. Renal allograft function (eGFR), rejection, patient/graft survival and severe adverse events up to 12 months post enrollment are monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSCs group | Experimental | Other: BM-MSCsPatients with early poor graft function receive allogeneic BM-MSCs at the dose of 1*10^6/kg every week for four consecutive doses. |
| Control group | Placebo comparator | Other: SalinePatients with early poor graft function receive placebo of MSCs, i.e. saline every week for four consecutive doses. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary kidney transplantation
- Kidneys are from donation after Chinese citizen death
- Poor early graft function with or without dialysis after transplantation
- Patient is willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months
Key exclusion criteria (15 listed)
- Secondary kidney transplantation
- Combined or multi-organ transplantation
- Women who are pregnant, intend to become pregnant in the next 1 years, breastfeeding, or have a positive pregnancy test on enrollment or prior to study medication administration
- Panel reactive antibody (PRA)>20% or CDC crossmatch is positive
- Donors or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C
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 |
|---|---|---|
| BM-MSCsAlso: allogeneic bone marrow-derived MSCsBM-MSCs are from third-party healthy volunteer donors. | Other | MSCs group |
| SalineSaline is the placebo of MSCs in this study. | Other | Control group |
Primary outcome
Estimated glomerular filtration rate
Time frame: 1 month
eGFR at one month post transplant
6 secondary outcomes
Estimated glomerular filtration rate
Time frame: 12 months
Proportion of normal renal function recovery
Time frame: 12 months
Time to renal function recovery (days)
Time frame: 12 months
acute rejection rate
Time frame: 12 months
patient and graft survival rate
Time frame: 12 months
Incidence of severe adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
- Background: PubMed 23263506Peng Y, Ke M, Xu L, Liu L, Chen X, Xia W, Li X, Chen Z, Ma J, Liao D, Li G, Fang J, Pan G, Xiang AP. Donor-derived mesenchymal stem cells combined with low-dose tacrolimus prevent acute rejection after renal transplantation: a clinical pilot study. Transplantation. 2013 Jan 15;95(1):161-8. doi: 10.1097/TP.0b013e3182754c53.
- Previous publicationLink provided by the sponsor.
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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.
Changxi Wang, M.D., Ph.D study chair
First Affiliated Hospital, Sun Yat-Sen University
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 BM-MSCs and Saline in people with Kidney Transplantation and Acute Kidney Tubular Necrosis, run by First Affiliated Hospital, Sun Yat-Sen University 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 15 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 30 Sep 2015. 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?
Contact Changxi Wang, M.D., Ph.D (86-20-87333428, wangchx@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated glomerular filtration rate (time frame: 1 month). 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 NCT02563366, 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 30 Sep 2015.