Renal Transplant RejectionNCT00658073
Induction Therapy With Autologous Mesenchymal Stem Cells for Kidney Allografts
A study testing Kidney transplantation with MSCs infusion and kidney transplantation without MSC infusion in people with Renal Transplant Rejection, run by Fuzhou General Hospital at 1 site in China.
Trial summary
The goal of this study is to evaluate autologous MSCs as an alternative for antibody induction therapy in renal transplantation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Renal Transplant Rejection
- What is being tested?
- Kidney transplantation with MSCs infusion and kidney transplantation without MSC infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteChina
- Study dates
- Mar 2008to Oct 2010
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must be between the ages of 18 and 60 years and meet the institution's criteria for renal transplantation for end-stage renal failure
- Patient is receiving the first renal transplant
- Patient is receiving a renal transplant only
- Women who are of child bearing potential must have a negative pregnancy test (urine test is acceptable) and agree to use reliable contraception for 1 year following transplant
- Willing to comply with the study visits
- Be able to sign informed consent document.
- Note: The subjects do not need to be local residents in order to be eligible for this trial, but must be willing to reside in the area, or within a four hour drive, for the first three months of the protocol so that we can monitor them closely in the early post transplant period.
Who cannot join
- Previously received or is receiving an organ transplant other than a kidney
- Significant liver disease, defined as having continuously elevated AST (SGOT) or ALT (SGPT) levels greater than 3 times the upper value of the normal range within 28 days prior to study entry
- HIV infection.
- Surface antigen positive for HBV.
- Antibody positive for hepatitis C virus
- Recipient or donor is positive for tuberculosis (TB), under treatment for suspected TB, or previously exposed to TB
Show all 17Show fewer
- Currently receiving an investigational drug or received an investigational drug within 30 days prior to transplant.
- Currently receiving any immunosuppressive agent.
- Clinically active bacterial, fungal, viral or parasitic infection
- Evidence for immunologic memory against donor.
- Recipients need antibody induction treatment before the operation.
- Current cancer or a history of cancer within the 5 years prior to study entry.
- Serious heart and lung diseases.
- Patients who's RPR is positive
- Pregnancy or breastfeeding.
- Have no ability to communicate.
- Any form of substance abuse, psychiatric disorder, or other condition that, in opinion of the investigator, may interfere with the study
Trial locations and contacts
1 site in 1 country.
China1 site
Stem cell therapy center,Fuzhou General Hospital
Fuzhou, Fujian, 350025
About this study
Official title: Autologous Bone Marrow Mesenchymal Stem Cell Transplantation in Recipients of Living Kidney Allografts
The goal of this study is to evaluate autologous MSCs as an alternative for antibody induction therapy in renal transplantation.
Read the detailed description
Renal transplantation is the most common and successful type of organ transplantation. Induction therapy with antibody plus the maintenance immunosuppressive agents have greatly improved graft survival in renal transplantation. Since mesenchymal stem cells(MSCs)have been used successfully to treat graft versus host disease and show immune modulation function both in vitro and in vivo and may help in repairing damaged tissue(s), we evaluate autologous MSCs as an alternative for antibody induction therapy. Moreover, we examine if MSCs could improve the recovery of early function in transplanted kidney.
- Conditions
- Renal Transplant Rejection
- Being tested
- Kidney transplantation with MSCs infusion, kidney transplantation without MSC infusion
- Keywords
- Kidney transplant, Mesenchymal stem cell (MSC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney transplantation with MSCs infusionProcedure or surgery
Also called MSCs induction plus a standard or a lower dose of CNI
Patients in Group A will receive the first MSCs infusion intravenously within 24 hours after kidney transplant operation , and the second infusion of MSCs will be performed two weeks later.
kidney transplantation without MSC infusionProcedure or surgery
Also called Anti-IL2R induction therapy with standard dose of CNI
kidney transplantation with standard immunosuppressive treatment regime
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Patients in Group A will receive MSCs instead of anti-interleukin 2 receptor antibody for induction therapy. The first MSCs infusion intravenously will be right at releasing renal artery clamp to establish allograft blood flow and the second infusion of MSCs will be performed two weeks after transplantation. Patients will receive standard regular immunosuppressive agents including calcineurin inhibitor, glucocorticoid, and MMF. Receives: Procedure: Kidney transplantation with MSCs infusion |
| B | Active comparator | Patients in Group B will receive MSCs instead of anti-interleukin 2 receptor antibody for induction therapy. The first MSCs infusion intravenously will be right at releasing renal artery clamp to establish allograft blood flow and the second infusion of MSCs will be performed two weeks after transplantation. Patients will receive 80% less of calcineurin inhibitor than in Group A. Other immunosuppressive agents such as glucocorticoid and MMF remained the same doses as in Group A. Receives: Procedure: Kidney transplantation with MSCs infusion |
| C | Active comparator | Patients in Group C will receive anti-interleukin 2 receptor antibody (Basiliximab)for induction therapy. Patients will receive the same doses of regular immunosuppressive agents including calcineurin inhibitor, glucocorticoid, and MMF as in Group A. Receives: Procedure: kidney transplantation without MSC infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of biopsy-proven acute rejection and early renal function recovery
Measured: At 1 year post-transplant
Secondary outcomes (1)
Patient and graft survival and prevalence of adverse events
Measured: At 1 year post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2010
- Study completionOct 2010
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 Renal Transplant RejectionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fuzhou General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jianming Tan, M.D and Ph.D, Study director, Fuzhou General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658073
- Sponsor's protocol ID
- MSC-K-2
- Status last verified
- Feb 2011
- First submitted
- 8 Apr 2008
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tan J, Wu W, Xu X, Liao L, Zheng F, Messinger S, Sun X, Chen J, Yang S, Cai J, Gao X, Pileggi A, Ricordi C. Induction therapy with autologous mesenchymal stem cells in living-related kidney transplants: a randomized controlled trial. JAMA. 2012 Mar 21;307(11):1169-77. doi: 10.1001/jama.2012.316.
PubMed 22436957
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Bone Marrow Mesenchymal Stem Cell Transplantation in Recipients of Living Kidney Allografts
- ClinicalTrials.gov ID
- NCT00658073
- Acronym / sponsor ID
- MSC-K-2
- Conditions
- Renal Transplant Rejection
- Keywords
- Kidney transplant, Mesenchymal stem cell (MSC)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Fuzhou General HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 14 Apr 2008 (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.
The goal of this study is to evaluate autologous MSCs as an alternative for antibody induction therapy in renal transplantation.
Detailed description
Renal transplantation is the most common and successful type of organ transplantation. Induction therapy with antibody plus the maintenance immunosuppressive agents have greatly improved graft survival in renal transplantation. Since mesenchymal stem cells(MSCs)have been used successfully to treat graft versus host disease and show immune modulation function both in vitro and in vivo and may help in repairing damaged tissue(s), we evaluate autologous MSCs as an alternative for antibody induction therapy. Moreover, we examine if MSCs could improve the recovery of early function in transplanted kidney.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: Kidney transplantation with MSCs infusionPatients in Group A will receive MSCs instead of anti-interleukin 2 receptor antibody for induction therapy. The first MSCs infusion intravenously will be right at releasing renal artery clamp to establish allograft blood flow and the second infusion of MSCs will be performed two weeks after transplantation. Patients will receive standard regular immunosuppressive agents including calcineurin inhibitor, glucocorticoid, and MMF. |
| B | Active comparator | Procedure: Kidney transplantation with MSCs infusionPatients in Group B will receive MSCs instead of anti-interleukin 2 receptor antibody for induction therapy. The first MSCs infusion intravenously will be right at releasing renal artery clamp to establish allograft blood flow and the second infusion of MSCs will be performed two weeks after transplantation. Patients will receive 80% less of calcineurin inhibitor than in Group A. Other immunosuppressive agents such as glucocorticoid and MMF remained the same doses as in Group A. |
| C | Active comparator | Procedure: kidney transplantation without MSC infusionPatients in Group C will receive anti-interleukin 2 receptor antibody (Basiliximab)for induction therapy. Patients will receive the same doses of regular immunosuppressive agents including calcineurin inhibitor, glucocorticoid, and MMF as in Group A. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients must be between the ages of 18 and 60 years and meet the institution's criteria for renal transplantation for end-stage renal failure
- Patient is receiving the first renal transplant
- Patient is receiving a renal transplant only
- Women who are of child bearing potential must have a negative pregnancy test (urine test is acceptable) and agree to use reliable contraception for 1 year following transplant
- Willing to comply with the study visits
Key exclusion criteria (17 listed)
- Previously received or is receiving an organ transplant other than a kidney
- Significant liver disease, defined as having continuously elevated AST (SGOT) or ALT (SGPT) levels greater than 3 times the upper value of the normal range within 28 days prior to study entry
- HIV infection.
- Surface antigen positive for HBV.
- Antibody positive for hepatitis C virus
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 |
|---|---|---|
| Kidney transplantation with MSCs infusionAlso: MSCs induction plus a standard or a lower dose of CNIPatients in Group A will receive the first MSCs infusion intravenously within 24 hours after kidney transplant operation , and the second infusion of MSCs will be performed two weeks later. | Procedure or surgery | A, B |
| kidney transplantation without MSC infusionAlso: Anti-IL2R induction therapy with standard dose of CNIkidney transplantation with standard immunosuppressive treatment regime | Procedure or surgery | C |
Primary outcome
Incidence rate of biopsy-proven acute rejection and early renal function recovery
Time frame: At 1 year post-transplant
1 secondary outcome
Patient and graft survival and prevalence of adverse events
Time frame: At 1 year post-transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2011.
- Derived from this study: PubMed 22436957Tan J, Wu W, Xu X, Liao L, Zheng F, Messinger S, Sun X, Chen J, Yang S, Cai J, Gao X, Pileggi A, Ricordi C. Induction therapy with autologous mesenchymal stem cells in living-related kidney transplants: a randomized controlled trial. JAMA. 2012 Mar 21;307(11):1169-77. doi: 10.1001/jama.2012.316.
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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.
Jianming Tan, M.D and Ph.D study director
Fuzhou General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kidney transplantation with MSCs infusion and kidney transplantation without MSC infusion in people with Renal Transplant Rejection, run by Fuzhou 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 7 inclusion and 17 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: finished, as of the sponsor's last update on 8 Mar 2011. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence rate of biopsy-proven acute rejection and early renal function recovery (time frame: At 1 year post-transplant). 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 NCT00658073, 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 8 Mar 2011.