Chronic Renal FailurePhase 1NCT02565459
MSC and Kidney Transplant Tolerance (Phase A)
A Phase 1 study testing Mesenchymal Stromal Cells in people with Chronic Renal Failure, run by Monia Lorini at 1 site in Italy.
Trial summary
The general aim of the present study is to test a cell therapy with third-party ex-vivo expanded bone marrow-derived mesenchymal stromal cells (MSCs) as a strategy to induce tolerance in kidney transplant recipients with a deceased donor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Renal Failure
- 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
- 22 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2015to Dec 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First single kidney transplant;
- Capable of understanding the purpose and risk of the study;
- Written informed consent.
Who cannot join
- PRA >10%;
- Specific contraindication to MSC infusion;
- Any clinical relevant condition that might affect study participation and/or study results;
- Childbearing potential without effective contraception;
- 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.
Italy1 site, 1 recruiting
- Recruiting
U.O. Nefrologia e Dialisi
Bergamo, 24127
Piero Ruggenenti, MD, 0039 035 2674037, pruggenenti@hpg23.it
Eliana Gotti, MD
About this study
Official title: Third-party Bone Marrow-derived Mesenchymal Stromal Cells to Induce Tolerance in Recipients of Kidney Transplants From Deceased Donors (Phase A)
The general aim of the present study is to test a cell therapy with third-party ex-vivo expanded bone marrow-derived mesenchymal stromal cells (MSCs) as a strategy to induce tolerance in kidney transplant recipients with a deceased donor. MSCs will be prepared accordingly to established protocols, starting from the remnants in the bag and filter at the end of the bone marrow infusions. 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.
The proposed study will be developed in two phases: i) a pilot explorative safety/biologic-mechanistic phase (Phase A), ii) a pilot efficacy phase (Phase B).
- Conditions
- Chronic Renal Failure
- Being tested
- Mesenchymal Stromal Cells
- Keywords
- Mesenchymal stromal cells, kidney transplantation, tolerance
- Medical subject headings
- Kidney Failure, Chronic
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 (MSC) | Experimental | A single intravenous infusion (1-2 millions of MSCs per kilogram body weight) of ex-vivo expanded third-party (from healthy donors) MSCs will be performed in patients randomized to the MSC procedure in addition to the kidney transplantation. Receives: Biological: Mesenchymal Stromal Cells |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
At each visit overall clinical condition of the patient will be evaluated and any adverse event will be recorded.
Measured: Changes from baseline through study completion, up to 12 months after transplant.
Circulating naive and memory T cell count (CD45RA/CD45RO) (flow cytometry analysis)
Measured: Changes from baseline at 7, 14, 30 days after transplant and then every six months through study completion, up to 12 months after transplant.
Circulating regulatory T cell count.
Measured: Changes from baseline at 7, 14, 30 days after transplant and then every six months through study completion, up to 12 months after transplant.
T-cell function in mixed lymphocyte reaction.
IFNg-producing T cells (spots/300.000 cells) and CD8+ T cell-mediated cytotoxicity (percentage of specific lysis) will be measured in mixed lymphocyte reaction.
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 posted1 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monia Lorini
- Sponsor type
- University, hospital or other
- Collaborators
- Mario Negri Institute for Pharmacological Research
- Responsible party
- Sponsor-investigator, Monia Lorini, A.O. Ospedale Papa Giovanni XXIII
- 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
- NCT02565459
- Sponsor's protocol ID
- Third-party MSC-Tx tolerance A
- Other IDs
- 2015-002186-27, 2015
- Status last verified
- Apr 2018
- First submitted
- 24 Sep 2015
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Third-party Bone Marrow-derived Mesenchymal Stromal Cells to Induce Tolerance in Recipients of Kidney Transplants From Deceased Donors (Phase A)
- ClinicalTrials.gov ID
- NCT02565459
- Acronym / sponsor ID
- Third-party MSC-Tx tolerance A
- Conditions
- Chronic Renal Failure
- Keywords
- Mesenchymal stromal cells, kidney transplantation, tolerance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Monia LoriniUniversity, hospital or other
- Collaborators
- Mario Negri Institute for Pharmacological Research
- Study start
- Sep 2015
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 1 Oct 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 general aim of the present study is to test a cell therapy with third-party ex-vivo expanded bone marrow-derived mesenchymal stromal cells (MSCs) as a strategy to induce tolerance in kidney transplant recipients with a deceased donor. MSCs will be prepared accordingly to established protocols, starting from the remnants in the bag and filter at the end of the bone marrow infusions. 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.
The proposed study will be developed in two phases: i) a pilot explorative safety/biologic-mechanistic phase (Phase A), ii) a pilot efficacy phase (Phase B).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal Stromal Cells (MSC) | Experimental | Biological: Mesenchymal Stromal CellsA single intravenous infusion (1-2 millions of MSCs per kilogram body weight) of ex-vivo expanded third-party (from healthy donors) MSCs will be performed in patients randomized to the MSC procedure in addition to the kidney transplantation. |
| No intervention | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First single kidney transplant;
- Capable of understanding the purpose and risk of the study;
- Written informed consent.
Key exclusion criteria (6 listed)
- PRA >10%;
- Specific contraindication to MSC infusion;
- Any clinical relevant condition that might affect study participation and/or study results;
- Childbearing potential without effective contraception;
- Pregnant women and nursing mothers;
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 (MSC) |
Primary outcome
Number of adverse events
Time frame: Changes from baseline through study completion, up to 12 months after transplant.
At each visit overall clinical condition of the patient will be evaluated and any adverse event will be recorded.
Circulating naive and memory T cell count (CD45RA/CD45RO) (flow cytometry analysis)
Time frame: Changes from baseline at 7, 14, 30 days after transplant and then every six months through study completion, up to 12 months after transplant.
Circulating regulatory T cell count.
Time frame: Changes from baseline at 7, 14, 30 days after transplant and then every six months through study completion, up to 12 months after transplant.
T-cell function in mixed lymphocyte reaction.
Time frame: Changes from baseline at 6 and 12 months after transplant.
IFNg-producing T cells (spots/300.000 cells) and CD8+ T cell-mediated cytotoxicity (percentage of specific lysis) will be measured in mixed lymphocyte reaction.
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 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 Chronic Renal Failure, run by Monia Lorini 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 3 inclusion and 6 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 6 Apr 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Norberto Perico, MD (0039 035 45351, norberto.perico@marionegri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: Changes from baseline through study completion, up to 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?
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 6 Apr 2018.