InterventionalNCT03585855
Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Antibody Mediated Kidney Graft Rejection (ABMR)
A study testing MSC transplantation in people with Interventional, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
Transplant rejection is one of the biggest limitations in renal transplant procedures, where the kidney can undergo an acute, late acute, or chronic transplant rejection. With the advancement in transplantation protocols, acute survival of renal transplants has improved, but long-term survival is still unsatisfactory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interventional
- What is being tested?
- MSC transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2019to 23 Jul 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipients of a renal allograft, male and female patients age >18
- The eGF>20 ml/min/1.73 m2,
- Renal biopsy Criteria: chronic active ABMR.
- Written informed consent, compliant with local regulations.
Who cannot join
- Recipients of multiple organs.
- Pregnant women.
- Malignant disease in last 5 years
- Active autoimmune disease
- Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis
- Evidence of congestive cardiac failure and/or acute coronary syndrome in past 6 months.
- Evidence of liver disease
- Inadequate compliance to treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autologous Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Antibody Mediated Kidney Graft Rejection (ABMR)
Transplant rejection is one of the biggest limitations in renal transplant procedures, where the kidney can undergo an acute, late acute, or chronic transplant rejection. With the advancement in transplantation protocols, acute survival of renal transplants has improved, but long-term survival is still unsatisfactory, as most of the renal transplants develop chronic graft rejection. Unfortunately, there is little the investigators know when it comes to improving long-term survival of renal transplants. Mesenchymal stem cells (MSC) have been shown to have immunosuppressive and repairing properties. The purpose of this study is to find out whether MSC in combination with standard therapy of antibody mediated rejection (ABMR) are more effective in preventing organ deterioration and maintaining kidney function.
Read the detailed description
Participants will be assigned to receive the full immunosuppressive therapy indicated to treat chronic ABMR (including plasmapheresis (PF) 7x, intravenous immune globulins 100 mg/kg 7x, corticosteroid) and MSC infusions (2x106cells/kg bw after PF) (Group 1) and be compared to historic controls according to "propensity score matching" (treated with immunosuppressive therapy alone (Group 2)). Patients will undergo MSC infusions at the start of the study after each PF. One year post- infusions, patients will be evaluated and undergo kidney biopsies. Blood collection will occur at regular intervals, serum creatinine and the estimated creatinine clearance will be monthly recorded. The transplanted kidney function and morphology (US Doppler) will be evaluated.
- Conditions
- Interventional
- Being tested
- MSC transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSC transplantationOther
MSC transplantation: patients with ABMR treated with MSC transplantation
| Study group | Role | What they receive |
|---|---|---|
| Historic control | No intervention | historic cohort of patients with ABMR treated with standard of care therapy |
| MSC transplantation | Experimental | patients with ABMR treated with MSC transplantation Receives: Other: MSC transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of MSC transplantation as assessed by adverse events according to CTCAE Version 5Estimated glomerular filtration rate (eGFR)
Adverse events according to CTCAE Version 5
Measured: 12 months
Secondary outcomes (2)
Estimated glomerular filtration rate (eGFR)
eGFR at up to 12 months post MSC transplantation
Measured: 12 months
Graft survival rate
Graft survival rate at 12 months post MSC 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 posted13 Jul 2018
- Study start1 Jan 2019
- Primary completion23 Jul 2019
- Study completion23 Jul 2019
Why it stopped: Safety reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InterventionalStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- comparison with historic control
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- Slovenian Research Agency
- Responsible party
- Principal investigator, Veceric-Haler Zeljka, University Medical Centre Ljubljana
- Investigators
- Željka Večerić-Haler, MDPhD, Principal investigator, assist.prof.Željka Večerić-Haler, MDPhD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03585855
- Sponsor's protocol ID
- P3-0323
- Status last verified
- Jul 2019
- First submitted
- 25 Jun 2018
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 12 months
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Mesenchymal Stem Cell Transplantation in the Treatment of Chronic Antibody Mediated Kidney Graft Rejection (ABMR)
- ClinicalTrials.gov ID
- NCT03585855
- Acronym / sponsor ID
- P3-0323
- Conditions
- Interventional
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety reasons
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- Slovenian Research Agency
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 23 Jul 2019 (actual)
- Study completion
- 23 Jul 2019 (actual)
- First posted
- 13 Jul 2018 (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.
Transplant rejection is one of the biggest limitations in renal transplant procedures, where the kidney can undergo an acute, late acute, or chronic transplant rejection. With the advancement in transplantation protocols, acute survival of renal transplants has improved, but long-term survival is still unsatisfactory, as most of the renal transplants develop chronic graft rejection. Unfortunately, there is little the investigators know when it comes to improving long-term survival of renal transplants. Mesenchymal stem cells (MSC) have been shown to have immunosuppressive and repairing properties. The purpose of this study is to find out whether MSC in combination with standard therapy of antibody mediated rejection (ABMR) are more effective in preventing organ deterioration and maintaining kidney function.
Detailed description
Participants will be assigned to receive the full immunosuppressive therapy indicated to treat chronic ABMR (including plasmapheresis (PF) 7x, intravenous immune globulins 100 mg/kg 7x, corticosteroid) and MSC infusions (2x106cells/kg bw after PF) (Group 1) and be compared to historic controls according to "propensity score matching" (treated with immunosuppressive therapy alone (Group 2)). Patients will undergo MSC infusions at the start of the study after each PF. One year post- infusions, patients will be evaluated and undergo kidney biopsies. Blood collection will occur at regular intervals, serum creatinine and the estimated creatinine clearance will be monthly recorded. The transplanted kidney function and morphology (US Doppler) will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- comparison with historic control
| Arm | Type | Receives |
|---|---|---|
| Historic control | No intervention | –historic cohort of patients with ABMR treated with standard of care therapy |
| MSC transplantation | Experimental | Other: MSC transplantationpatients with ABMR treated with MSC transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recipients of a renal allograft, male and female patients age >18
- The eGF>20 ml/min/1.73 m2,
- Renal biopsy Criteria: chronic active ABMR.
- Written informed consent, compliant with local regulations.
Key exclusion criteria (8 listed)
- Recipients of multiple organs.
- Pregnant women.
- Malignant disease in last 5 years
- Active autoimmune disease
- Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis
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 |
|---|---|---|
| MSC transplantationMSC transplantation: patients with ABMR treated with MSC transplantation | Other | MSC transplantation |
Primary outcome
Safety of MSC transplantation as assessed by adverse events according to CTCAE Version 5Estimated glomerular filtration rate (eGFR)
Time frame: 12 months
Adverse events according to CTCAE Version 5
2 secondary outcomes
Estimated glomerular filtration rate (eGFR)
Time frame: 12 months
Graft survival rate
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Safety reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
- Individual participant dataSharing planned: No. 12 months
Related trials for Interventional
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingObservational study
A Non-Interventional Study PASS to Characterize Secondary Malignancies of Tcell Origin Following Tisagenlecleucel Therapy
Secondary Malignancies of T-cell Origin
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
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.
Željka Večerić-Haler, MDPhD principal investigator
assist.prof.Željka Večerić-Haler, MDPhD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MSC transplantation in people with Interventional, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 8 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: stopped early, as of the sponsor's last update on 25 Jul 2019. 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 Slovenia. 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 was stopped early (reason given: Safety reasons). 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?
Safety of MSC transplantation as assessed by adverse events according to CTCAE Version 5Estimated glomerular filtration rate (eGFR) (time frame: 12 months). 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 25 Jul 2019.