UremiaPhase 1/2NCT02492490
Effect of SVF Derived MSC in DCD Renal Transplantation
A Phase 1/2 study testing SVFderived MSC transplantations and Basiliximab in people with Uremia, run by Fuzhou General Hospital at 1 site in China.
Trial summary
The objective of this trial is to determine if autologous Stromal Vascular Fraction (SVF) derived Mesenchymal Stem Cell (MSC) infusion during and after kidney transplantation from Donation after Citizen Death (DCD) can effectively reduce the need for post transplant immunosuppressant and elevate GFR of allograft. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Uremia
- What is being tested?
- SVFderived MSC transplantations and Basiliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Nov 2016
- 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
- Uremia patient of any race that is greater than or equal to 18 years of age but less than 60 years old
- Patient is willing to receive a kidney from DCD
- 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 22Show fewer
- 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
- Donors or recipients are known human immunodeficiency virus (HIV) infection
- 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)
- Recipients with any significant infection or other contraindication that would preclude transplant
- Recipients with a history of hypercoagulable state
- 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.
- Recipients with active peptic ulcer disease (PUD), chronic diarrhea, or gastrointestinal problem affect absorption
- Recipients with a history of cancer within the last 5 years (exception: non-melanoma skin cell cancers cured by local resection are permitted)
- Recipients with a chest radiograph (no more than 2 months prior to randomization) consistent with an acute lung parenchymal process and malignancy
- Recipients with a hypersensitivity to any study drugs
- Recipients who have used any investigational drug within 30 days prior to the Day 1 visit
- 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, 1 recruiting
- Recruiting
Fuzhou General Hospital, Xiamen Univ
Fuzhou, Fujian, 350025
Jianming Tan, professor, 008613375918000, doctortjm@yahoo.com
Xia Gao, MD, 8618065102725, 38704163@qq.com
About this study
Official title: Effect of Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cell in Kidney Transplantation From Chinese Donation After Citizen Death (DCD): A Randomized Controlled Trial
The objective of this trial is to determine if autologous Stromal Vascular Fraction (SVF) derived Mesenchymal Stem Cell (MSC) infusion during and after kidney transplantation from Donation after Citizen Death (DCD) can effectively reduce the need for post transplant immunosuppressant and elevate GFR of allograft. The investigators will infuse autologous SVF derived MSC to the recipients during and after operation to assess the effect of SVF derived MSC and closely monitor renal function, dosage of immunosuppressant, acute rejection, and graft survival. 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 DCD 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. Kidneys from the same donor of DCD will be random allocated to intervention group and control group. In intervention group the investigators 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 DCD kidney transplantation during operation and on 7, 14, 21 POD. The investigators will assess whether induction therapy with autologous SVF derived MSC is feasible in DCD 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, the investigators 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
- Uremia
- Being tested
- SVFderived MSC transplantations, Basiliximab
- Keywords
- Kidney transplantation, DCD, Stromal Vascular Fraction, MSC
- Medical subject headings
- Uremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SVFderived MSC transplantationsOther
infusion of autologous SVF derived MSC to the recipients of DCD 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. And the induction therapy of control group will be Basiliximab.
BasiliximabDrug
induction with Basiliximab before kidney transplantation and on POD 4
| Study group | Role | What they receive |
|---|---|---|
| SVF(Stromal Vascular Fraction) derived MSC transprlantation | Experimental | transplantation of autologous SVF derived MSC to the recipients of DCD kidney transplant.
1. Subjects with uremia in the intervention group will undergo puncture to collect SVF
2. SVF will be cultured to abstain MSC
3. The abstained MSC will be infused to the recipients during kidney transplant operation and on 7, 14, and 21 POD. Receives: Other: SVFderived MSC transplantations |
| Basiliximab | Active comparator | induction with Basiliximab during kidney transplantation from DCD Receives: Drug: Basiliximab |
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 CNI by 30% in Kidney Transplantation from Chinese Donation after Citizen Death
Changes of the immunosuppressant by reducing 30% of CNI dosage.
Measured: 1 years
Secondary outcomes (6)
Changes in renal function as determined by eGFR and proteinuria
Changes in renal function as determined by estimated glomerular filtration rate (eGFR) and proteinuria (>1g)
Measured: 1 year
Incidence of Acute rejection
Incidence of acute rejection (biopsy confirmed acute rejection)
Measured: 1 year
Incidence of delayed graft function (DGF)
Incidence of delayed graft function (defined as need for post-transplant dialysis within one week)
Measured: 3 months
Allograft survival
Allograft survival at 1 year post transplant
Measured: 1 year
SAE (severe adverse effects)
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
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 completionNov 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UremiaStudies 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492490
- Sponsor's protocol ID
- SVF-DCD
- Status last verified
- Nov 2014
- First submitted
- 20 May 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 Kidney Transplantation From Chinese Donation After Citizen Death (DCD): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02492490
- Acronym / sponsor ID
- SVF-DCD
- Conditions
- Uremia
- Keywords
- Kidney transplantation, DCD, Stromal Vascular Fraction, 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
- Nov 2016 (estimated)
- Study completion
- Nov 2016 (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 Stromal Vascular Fraction (SVF) derived Mesenchymal Stem Cell (MSC) infusion during and after kidney transplantation from Donation after Citizen Death (DCD) can effectively reduce the need for post transplant immunosuppressant and elevate GFR of allograft. The investigators will infuse autologous SVF derived MSC to the recipients during and after operation to assess the effect of SVF derived MSC and closely monitor renal function, dosage of immunosuppressant, acute rejection, and graft survival. 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 DCD 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. Kidneys from the same donor of DCD will be random allocated to intervention group and control group. In intervention group the investigators 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 DCD kidney transplantation during operation and on 7, 14, 21 POD. The investigators will assess whether induction therapy with autologous SVF derived MSC is feasible in DCD 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, the investigators 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(Stromal Vascular Fraction) derived MSC transprlantation | Experimental | Other: SVFderived MSC transplantationstransplantation of autologous SVF derived MSC to the recipients of DCD kidney transplant. 1. Subjects with uremia in the intervention group will undergo puncture to collect SVF 2. SVF will be cultured to abstain MSC 3. The abstained MSC will be infused to the recipients during kidney transplant operation and on 7, 14, and 21 POD. |
| Basiliximab | Active comparator | Drug: Basiliximabinduction with Basiliximab during kidney transplantation from DCD |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Uremia patient of any race that is greater than or equal to 18 years of age but less than 60 years old
- Patient is willing to receive a kidney from DCD
- 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 (22 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 |
|---|---|---|
| SVFderived MSC transplantationsinfusion of autologous SVF derived MSC to the recipients of DCD 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. And the induction therapy of control group will be Basiliximab. | Other | SVF(Stromal Vascular Fraction) derived MSC transprlantation |
| Basiliximabinduction with Basiliximab before kidney transplantation and on POD 4 | Drug | Basiliximab |
Primary outcome
Effects of autologous SVF derived MSC transplantation on reducing the dosage of CNI by 30% in Kidney Transplantation from Chinese Donation after Citizen Death
Time frame: 1 years
Changes of the immunosuppressant by reducing 30% of CNI dosage.
6 secondary outcomes
Changes in renal function as determined by eGFR and proteinuria
Time frame: 1 year
Incidence of Acute rejection
Time frame: 1 year
Incidence of delayed graft function (DGF)
Time frame: 3 months
Allograft survival
Time frame: 1 year
SAE (severe adverse effects)
Time frame: 1 year
non-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.
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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.
Tan Jianming, MD, PhD 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 Phase 1/2 study testing SVFderived MSC transplantations and Basiliximab in people with Uremia, 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 3 inclusion and 22 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 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.
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 CNI by 30% in Kidney Transplantation from Chinese Donation after Citizen Death (time frame: 1 years). 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.