Kidney Transplant RejectionPhase 1NCT02012153
Mesenchymal Stromal Cells in Kidney Transplant Recipients
A Phase 1 study testing Mesenchymal Stromal Cells in people with Kidney Transplant Rejection, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
Trial summary
The general aim of the present study is to test a cell therapy with autologous ex-vivo expanded mesenchymal stromal cells (MSCs) as a strategy to induce tolerance in living-donor kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- Mesenchymal Stromal Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteItaly
- Study dates
- 4 Dec 2013to 29 May 2023
- Phase
- Phase 1
- 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
- Male and female patients;
- Aged 18 or older;
- Living-donor (related and unrelated, spouse/husband) kidney transplant recipients;
- Non-Human Leukocyte Antigen (HLA) identical with the donor (one or two haplotype mismatches);
- First kidney transplant;
- Capable of understanding the purpose and risk of the study;
- Written informed consent.
Who cannot join
- MSC donor positive for HIV-1, HIV-2, hepatitis B virus (HBV),hepatitis C virus (HCV), syphilis;
- Specific contraindication to MSC infusion;
- Any clinical relevant condition that might affect study participation and/or study results;
- Pregnant women and nursing mothers;
- Unwillingness or inability to follow study protocol in the investigator's opinion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autologous Mesenchymal Stromal Cells to Induce Tolerance in Living-donor Kidney Transplant Recipients
The general aim of the present study is to test a cell therapy with autologous ex-vivo expanded mesenchymal stromal cells (MSCs) as a strategy to induce tolerance in living-donor kidney transplant recipients. MSCs will be prepared accordingly to established protocols, starting from bone marrow explants of living-donor kidney transplant recipients obtained 3-4 months before kidney transplant. From these samples, MSCs will be expanded in Good Manufacturing Practice (GMP) approved facilities and used for the present study in patients undergoing kidney transplantation.
- Conditions
- Kidney Transplant Rejection
- Being tested
- Mesenchymal Stromal Cells
- Keywords
- Mesenchymal stromal cells, Kidney transplantation, Tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stromal CellsBiological
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal Stromal Cells | Experimental | A single intravenous infusion of ex-vivo expanded autologous MSCs will be performed in patients in addition to the living-donor kidney transplantation.
2x10 elevated to sxth power MSCs per kilogram body weight previously isolated from the same recipient will be infused intravenously the day before the kidney transplant procedure. Receives: Biological: Mesenchymal Stromal Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating naïve and memory T cell count (CD45RA/CD45RO) (flow cytometry analysis).
Measured: Changes from baseline at 6 and 12 months after transplant.
T-cell function by ELISPOT assay in mixed lymphocyte reaction.
Measured: Changes from baseline at 6 and 12 months after transplant.
Number of adverse events.
At each visit the overall clinical condition of the patient will be evaluated and any adverse event will be recorded.
Measured: Changes from baseline up to 48 months.
Circulating regulatory T cell count.
Measured: Changes from baseline at 6 and 12 months after transplant.
Urinary FOXP3 mRNA expression evaluated by real time quantitative PCR.
Measured: Changes from baseline at 6 and 12 months after transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study start4 Dec 2013
- Primary completion29 May 2023
- Study completion29 May 2023
Why it stopped: Failure to enroll the number of patients required by the protocol due to the low number of living donor transplants performed at the Clinical Center
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 Transplant RejectionStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- A.O. Ospedale Papa Giovanni XXIII
- Responsible party
- Sponsor
- Investigators
- Giuseppe Remuzzi, MD, Study chair, A.O. Ospedale Papa Giovanni XXIIINorberto Perico, MD, Study director, Istituto Di Ricerche Farmacologiche Mario NegriGiovanni Rota, MD, Principal investigator, A.O. Ospedale Papa Giovanni XXIIIFederica Casiraghi, Principal investigator, Istituto Di Ricerche Farmacologiche Mario NegriMartino Introna, MD, Principal investigator, Laboratorio G. Lanzani, Bergamo, ItalyAlessandro Rambaldi, MD, Principal investigator, A.O. Ospedale Papa Giovanni XXIII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012153
- Sponsor's protocol ID
- MSC-Tx tolerance
- Other IDs
- 2013-003221-29
- Status last verified
- May 2023
- First submitted
- 29 Nov 2013
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Perico N, Casiraghi F, Todeschini M, Cortinovis M, Gotti E, Portalupi V, Mister M, Gaspari F, Villa A, Fiori S, Introna M, Longhi E, Remuzzi G. Long-Term Clinical and Immunological Profile of Kidney Transplant Patients Given Mesenchymal Stromal Cell Immunotherapy. Front Immunol. 2018 Jun 14;9:1359. doi: 10.3389/fimmu.2018.01359. eCollection 2018.
PubMed 29963053
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Mesenchymal Stromal Cells to Induce Tolerance in Living-donor Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT02012153
- Acronym / sponsor ID
- MSC-Tx tolerance
- Conditions
- Kidney Transplant Rejection
- Keywords
- Mesenchymal stromal cells, Kidney transplantation, Tolerance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Failure to enroll the number of patients required by the protocol due to the low number of living donor transplants performed at the Clinical Center
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- A.O. Ospedale Papa Giovanni XXIII
- Study start
- 4 Dec 2013 (actual)
- Primary completion
- 29 May 2023 (actual)
- Study completion
- 29 May 2023 (actual)
- First posted
- 16 Dec 2013 (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 general aim of the present study is to test a cell therapy with autologous ex-vivo expanded mesenchymal stromal cells (MSCs) as a strategy to induce tolerance in living-donor kidney transplant recipients. MSCs will be prepared accordingly to established protocols, starting from bone marrow explants of living-donor kidney transplant recipients obtained 3-4 months before kidney transplant. From these samples, MSCs will be expanded in Good Manufacturing Practice (GMP) approved facilities and used for the present study in patients undergoing kidney transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal Stromal Cells | Experimental | Biological: Mesenchymal Stromal CellsA single intravenous infusion of ex-vivo expanded autologous MSCs will be performed in patients in addition to the living-donor kidney transplantation. 2x10 elevated to sxth power MSCs per kilogram body weight previously isolated from the same recipient will be infused intravenously the day before the kidney transplant procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female patients;
- Aged 18 or older;
- Living-donor (related and unrelated, spouse/husband) kidney transplant recipients;
- Non-Human Leukocyte Antigen (HLA) identical with the donor (one or two haplotype mismatches);
- First kidney transplant;
Key exclusion criteria (5 listed)
- MSC donor positive for HIV-1, HIV-2, hepatitis B virus (HBV),hepatitis C virus (HCV), syphilis;
- Specific contraindication to MSC infusion;
- Any clinical relevant condition that might affect study participation and/or study results;
- Pregnant women and nursing mothers;
- Unwillingness or inability to follow study protocol in the investigator's opinion.
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 |
|---|---|---|
| Mesenchymal Stromal Cells | Biological | Mesenchymal Stromal Cells |
Primary outcome
Circulating naïve and memory T cell count (CD45RA/CD45RO) (flow cytometry analysis).
Time frame: Changes from baseline at 6 and 12 months after transplant.
T-cell function by ELISPOT assay in mixed lymphocyte reaction.
Time frame: Changes from baseline at 6 and 12 months after transplant.
Number of adverse events.
Time frame: Changes from baseline up to 48 months.
At each visit the overall clinical condition of the patient will be evaluated and any adverse event will be recorded.
Circulating regulatory T cell count.
Time frame: Changes from baseline at 6 and 12 months after transplant.
Urinary FOXP3 mRNA expression evaluated by real time quantitative PCR.
Time frame: Changes from baseline at 6 and 12 months after transplant.
Results and safety
The study was stopped early (reason given: Failure to enroll the number of patients required by the protocol due to the low number of living donor transplants performed at the Clinical Center). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Derived from this study: PubMed 29963053Perico N, Casiraghi F, Todeschini M, Cortinovis M, Gotti E, Portalupi V, Mister M, Gaspari F, Villa A, Fiori S, Introna M, Longhi E, Remuzzi G. Long-Term Clinical and Immunological Profile of Kidney Transplant Patients Given Mesenchymal Stromal Cell Immunotherapy. Front Immunol. 2018 Jun 14;9:1359. doi: 10.3389/fimmu.2018.01359. eCollection 2018.
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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.
Giuseppe Remuzzi, MD study chair
A.O. Ospedale Papa Giovanni XXIII
Norberto Perico, MD study director
Istituto Di Ricerche Farmacologiche Mario Negri
Giovanni Rota, MD principal investigator
A.O. Ospedale Papa Giovanni XXIII
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mesenchymal Stromal Cells in people with Kidney Transplant Rejection, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
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 5 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 1 Jun 2023. 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 Italy. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Failure to enroll the number of patients required by the protocol due to the low number of living donor transplants performed at the Clinical Center). 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?
Circulating naïve and memory T cell count (CD45RA/CD45RO) (flow cytometry analysis). (time frame: Changes from baseline at 6 and 12 months after transplant.). The study lists 5 primary outcomes in all. 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 NCT02012153, 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 1 Jun 2023.