Living-relative Kidney TransplantationPhase 1/2NCT02492308
Induction With SVF Derived MSC in Living-related Kidney Transplantation
A Phase 1/2 study testing SVF-MSC induction and Basiliximab induction in people with Living-relative Kidney Transplantation, run by Fuzhou General Hospital at 2 sites in China.
Trial summary
The objective of this trial is to determine if autologous SVF derived MSC can effectively reduce the need for post transplant immunosuppressant in living-relative kidney transplantation. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Living-relative Kidney Transplantation
- What is being tested?
- SVF-MSC induction and Basiliximab induction
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- Dec 2014to 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Uremia patient of any race that is greater than or equal to 18 years of age but less than 60 years old 2. Patient is willing to receive a kidney from a certifiable living-relative donor 18-60 years of age 3. 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
- 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
- Patient with prior solid organ transplant or cell transplant (e.g. bone marrow or islet cell).
- Patient is deemed likely to have a second solid organ transplant or cell transplant (e.g. bone marrow or islet cell) in next 3 years
- Patient receiving a concurrent SOT (heart, liver, pancreas)
- ABO incompatible donor recipient pair or CDC crossmatch positive transplant
- Sensitized patients (most recent anti-HLA Class I or II Panel Reactive Antibodies (PRA)>10% by a CDC-assay) or patients identified a high immunological risk by the transplant physician
Show all 13Show fewer
- Donors with cardiac death (non-heart beating donor) 8 Donors or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C
- 9. Donors or recipients are known hepatitis B surface antigen-positive or PCR positive for hepatitis B 10. Donors or recipients are known human immunodeficiency virus (HIV) infection 11. Recipients at risk for tuberculosis (TB)
- Current clinical, radiographic or laboratory evidence of active or latent TB as determined by local standard of care
- History of active TB:
- (I). Within the last 2 years, even if treated (II) Greater than 2 years ago, unless there is documentation of adequate treatment according to locally accepted clinical practice c. Recipients at risk of reactivation of TB precludes administration of conventional immunosuppressant (as determined by investigator and based upon appropriate evaluation) 12. Recipients with any significant infection or other contraindication that would preclude transplant 13. Recipients with a history of hypercoagulabale state 14. 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.
- 15. Recipients with active peptic ulcer disease (PUD), chronic diarrhea, or gastrointestinal problem affect absorption 16. Recipients with a history of cancer within the last 5 years (exception: non-melanoma skin cell cancers cured by local resection are permitted) 17. Recipients with a chest radiograph (no more than 2 months prior to randomization) consistent with an acute lung parenchymal process and malignancy 18. Recipients with a hypersensitivity to any study drugs 19. Recipients who have used any investigational drug within 30 days prior to the Day 1 visit 20. Prisoner or patients compulsorily detained (involuntarily incarcerated) for treatment or either a psychiatric or physical (e.g. infectious disease) illness
- -
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Xi er huan road No.156
Fuzhou, Fujian, 350000
Tan Jianming, MD, PhD, 8613375918000, doctortjm@yahoo.com
Gao Xia, MD, 8659122859175, 38704163@qq.com
- Recruiting
Xi er huan road No.156
Fuzhou, Fujian, 350000
Tan Jianming, MD, PhD, 861337598000, doctortjm@yahoo.com
Gao Xia, MD, 8659122859175, 38704163@qq.com
About this study
Official title: Effect of Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cell in Living-Related Kidney Transplants: A Randomized Controlled Trial
The objective of this trial is to determine if autologous SVF derived MSC can effectively reduce the need for post transplant immunosuppressant in living-relative kidney transplantation. 120 patients eligible for the study as described below will be enrolled, with 60 patients in intervention group and 60 in control group.
Read the detailed description
The objective of this trial is to determine if autologous SVF derived MSC can effectively reduce the need for post transplant immunosuppressant in living-relative kidney transplantation. Emphasis will be placed on the safety of autologous SVF derived MSC infusion, dosage of immunosuppressant, GFR, percentage of acute rejection. 120 patients eligible for the study as described below will be enrolled, with 60 patients in intervention group and 60 in control group. In interventional group we will collect SVF from recipients with special instruments before transplantation, and culture SVF to abstain MSC. The abstained MSC will be infused to the recipients of living-relative kidney transplantation during operation and on 7, 14, 21 POD. We will assess whether induction therapy with autologous SVF derived MSC is feasible in living-relative donor kidney transplantation. The effectiveness of autologous SVF derived MSC induction therapy on reducing of immunosuppressant, reducing the rate of rejection, elevating patient and allograft survival, improving allograft function from day 0 to 12 months after transplantation. Additionally, we will assess the percentage of acute rejection or antibody mediated rejection by Banff criteria, the incidence of delayed graft function (defined as the need for post-transplant dialysis within one week), and the incidence of adverse events including infection, grade 3 and above non-hematologic toxicities, and grade 4 hematologic toxicities.
- Conditions
- Living-relative Kidney Transplantation
- Being tested
- SVF-MSC induction, Basiliximab induction
- Keywords
- kidney, transplantation, MSC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SVF-MSC inductionProcedure or surgery
Procedure: infusion of autologous SVF derived MSC to the recipients of living-relative kidney transplant.
Subjects with uremia in the intervention group will undergo puncture to collect SVF, then SVF will be cultured to abstain MSC, and the abstained MSC will be infused to the recipients during kidney transplant operation and on 7, 14, and 21 POD
Basiliximab inductionDrug
The control group will be inducted with Basiliximab before living-relative kidney transplantation and on POD 4
| Study group | Role | What they receive |
|---|---|---|
| SVF-MSC induction | Experimental | 1. collection of autologous SVF
2. culture of SVF to abstain MSC
3. infusion of MSC during and after living-relative kidney transplantation Receives: Procedure: SVF-MSC induction |
| Basiliximab induction | Active comparator | The control group will be inducted with Basiliximab Receives: Drug: Basiliximab induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of autologous SVF derived MSC transplantation on reducing the dosage of immunosuppressant in living-related kidney transplant recipients.
Reducing the dosage of immunosuppressant by 30% of CNI in living-related kidney transplant recipients.
Measured: 1 year
Secondary outcomes (7)
Changes in renal function
- Changes in renal function as determined by estimated glomerular filtration rate (eGFR) and proteinuria (>1g) at 1 year post transplant
Measured: 1 year
Incidence of acute rejection
Incidence of acute rejection (biopsy confirmed acute rejection according to Banff creteria)
Measured: 1 year
Incidence of delayed graft function
Incidence of delayed graft function (defined as need for post-transplant dialysis within one week)
Measured: 1 month
Allograft survival
Allograft survival at 1 year post transplant
Measured: 1 year
Infection adverse event
Incidence of death, allograft loss, and hospitalization due to infection at 1 year.
Measured: 1 year
Non-hematologic toxicities
Incidence of grade 3 and above non-hematologic toxicities
Measured: 1 year
Hematologic toxicities
Incidence of grade 4 hematologic toxicities
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Living-relative Kidney TransplantationStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuzhou General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tan Jianming, MD PhD, Study director, Fuzhou General Hospital, Xiamen Univ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492308
- Sponsor's protocol ID
- SVF-LR
- Status last verified
- Jul 2015
- First submitted
- 4 Jul 2015
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cell in Living-Related Kidney Transplants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02492308
- Acronym / sponsor ID
- SVF-LR
- Conditions
- Living-relative Kidney Transplantation
- Keywords
- kidney, transplantation, MSC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fuzhou General HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 Jul 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.
The objective of this trial is to determine if autologous SVF derived MSC can effectively reduce the need for post transplant immunosuppressant in living-relative kidney transplantation. 120 patients eligible for the study as described below will be enrolled, with 60 patients in intervention group and 60 in control group.
Detailed description
The objective of this trial is to determine if autologous SVF derived MSC can effectively reduce the need for post transplant immunosuppressant in living-relative kidney transplantation. Emphasis will be placed on the safety of autologous SVF derived MSC infusion, dosage of immunosuppressant, GFR, percentage of acute rejection. 120 patients eligible for the study as described below will be enrolled, with 60 patients in intervention group and 60 in control group. In interventional group we will collect SVF from recipients with special instruments before transplantation, and culture SVF to abstain MSC. The abstained MSC will be infused to the recipients of living-relative kidney transplantation during operation and on 7, 14, 21 POD. We will assess whether induction therapy with autologous SVF derived MSC is feasible in living-relative donor kidney transplantation. The effectiveness of autologous SVF derived MSC induction therapy on reducing of immunosuppressant, reducing the rate of rejection, elevating patient and allograft survival, improving allograft function from day 0 to 12 months after transplantation. Additionally, we will assess the percentage of acute rejection or antibody mediated rejection by Banff criteria, the incidence of delayed graft function (defined as the need for post-transplant dialysis within one week), and the incidence of adverse events including infection, grade 3 and above non-hematologic toxicities, and grade 4 hematologic toxicities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SVF-MSC induction | Experimental | Procedure: SVF-MSC induction1. collection of autologous SVF 2. culture of SVF to abstain MSC 3. infusion of MSC during and after living-relative kidney transplantation |
| Basiliximab induction | Active comparator | Drug: Basiliximab inductionThe control group will be inducted with Basiliximab |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. Uremia patient of any race that is greater than or equal to 18 years of age but less than 60 years old 2. Patient is willing to receive a kidney from a certifiable living-relative donor 18-60 years of age 3. 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 (13 listed)
- 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
- Patient with prior solid organ transplant or cell transplant (e.g. bone marrow or islet cell).
- Patient is deemed likely to have a second solid organ transplant or cell transplant (e.g. bone marrow or islet cell) in next 3 years
- Patient receiving a concurrent SOT (heart, liver, pancreas)
- ABO incompatible donor recipient pair or CDC crossmatch positive transplant
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 |
|---|---|---|
| SVF-MSC inductionProcedure: infusion of autologous SVF derived MSC to the recipients of living-relative kidney transplant. Subjects with uremia in the intervention group will undergo puncture to collect SVF, then SVF will be cultured to abstain MSC, and the abstained MSC will be infused to the recipients during kidney transplant operation and on 7, 14, and 21 POD | Procedure or surgery | SVF-MSC induction |
| Basiliximab inductionThe control group will be inducted with Basiliximab before living-relative kidney transplantation and on POD 4 | Drug | Basiliximab induction |
Primary outcome
Effects of autologous SVF derived MSC transplantation on reducing the dosage of immunosuppressant in living-related kidney transplant recipients.
Time frame: 1 year
Reducing the dosage of immunosuppressant by 30% of CNI in living-related kidney transplant recipients.
7 secondary outcomes
Changes in renal function
Time frame: 1 year
Incidence of acute rejection
Time frame: 1 year
Incidence of delayed graft function
Time frame: 1 month
Allograft survival
Time frame: 1 year
Infection adverse event
Time frame: 1 year
Non-hematologic toxicities
Time frame: 1 year
Hematologic toxicities
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
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.
Tan Jianming, MD PhD study director
Fuzhou General Hospital, Xiamen Univ
2 sites 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 SVF-MSC induction and Basiliximab induction in people with Living-relative Kidney Transplantation, run by Fuzhou General Hospital at 2 sites 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 2 inclusion and 13 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 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 Tan Jianming, MD, PhD (8613375918000, tanjm156@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of autologous SVF derived MSC transplantation on reducing the dosage of immunosuppressant in living-related kidney transplant recipients. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2015.