Renal Transplant RejectionPhase 1NCT02409940
To Elucidate the Effect of Mesenchymal Stem Cells on the T Cell Repertoire of the Kidney Transplant Patients
A Phase 1 study testing Mesenchymal Stem Cells in people with Renal Transplant Rejection, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Despite being a miracle of modern medicine, solid organ transplant recipients are always at risk of rejection, and remain dependent on lifelong immunosuppression. Currently used immunosuppressive drugs suppress the potential of immune system and interfere with the metabolism of medications. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Transplant Rejection
- What is being tested?
- Mesenchymal Stem Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2013to Mar 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All the renal transplant recipients participating in the trial should undergo primary kidney transplant.
- Donor should be living and related to the patient.
- Kidney transplant recipients and donor should be willing to give informed consent form.
Who cannot join
- There should be no prior sensitization to the patients.
- Patients should not be participating in any other study
- Patients should not be suffering from any autoimmune disorders.
Trial locations and contacts
1 site in 1 country.
India1 site
Translational and Regenerative Medicine
Chandigarh, Chandigarh, 160012
About this study
Official title: A Randomized Trial to Elucidate Effect of Mesenchymal Stem Cells on Immune Modulation in Living Related Kidney Transplant Patients
Despite being a miracle of modern medicine, solid organ transplant recipients are always at risk of rejection, and remain dependent on lifelong immunosuppression. Currently used immunosuppressive drugs suppress the potential of immune system and interfere with the metabolism of medications. Cellular therapies currently being investigated for this purpose require the use of ablative radiotherapy. The investigators are using a less toxic strategy by harnessing the immunosuppressive potential of the MSCs in the Kidney Transplant (KTx) recipients and studying immunomodulation mediated by these cells in the KTx patients.
Hypothesis MSCs interfere with signalling of Immune cells like T cells, B cells and Dendritic cells which leads to improve graft survival of renal transplant patients.
Read more
Aim To investigate effect of MSCs on immune cell repertoire in a donor specific mediated response.
The investigators aim to collect peripheral blood from 30 patients (10 patients for autologous cell infusion and 10 for allogeneic (donor derived cell infusion) at various time intervals following MSC therapy. 10 patients serve as controls on standard dose of drugs but without MSC infusion. This peripheral blood would be utilized for isolation of mononuclear cells and performing various immune assays on these cells in a donor specific response.
Read the detailed description
This is an open label type of study having 3 groups of patients: 1st group comprising of patients that would undergo allogeneic (donor-derived) mesenchymal stem cell infusion, 2nd group that would undergo autologous (patient-derived) mesenchymal stem cells and the third group (control group) without any stem cell infusion. All the three groups would have standard dose of Immunosuppressive drugs. Initially the investigators want to recruit 10 patients in each group and would increase the group size if the investigators get promising results on the follow up. The investigators plan to follow up the patients upto 1-2 years for immune based assays and then continue the follow up for atleast 5 years.
- Conditions
- Renal Transplant Rejection
- Being tested
- Mesenchymal Stem Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem CellsBiological
Also called Mesenchymal Stromal Cells
These Mesenchymal stem cells are derived from bone marrow of either renal transplant patients or their donors depending upon the group of study.
| Study group | Role | What they receive |
|---|---|---|
| Autologus Mesenchymal Stem Cells | Experimental | This group would get two doses of mesenchymal stem cell (MSCs) infusion, one day pre transplant and 30 days post transplant. These MSCs would be derived from transplant recipient's bone marrow which are cultured in GMP compliant laboratories for 4-6 weeks. Receives: Biological: Mesenchymal Stem Cells |
| Allogeniec Mesenchymal Stem Cells | Active comparator | This group would get two doses of mesenchymal stem cell (MSCs) infusion, one day pre transplant and 30 days post transplant. These MSCs would be derived from transplant donor's bone marrow which are cultured in GMP compliant laboratories for 4-6 weeks. Receives: Biological: Mesenchymal Stem Cells |
| Control without Mesenchymal Stem Cells | No intervention | This group would get no stem cell infusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expansion of regulatory T cell compartment of the patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients.
Measured: 6 months
Normalization of serum creatinine levels of the patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients.
Measured: 6 months
Secondary outcomes (5)
T cell proliferation changes in patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients.
Measured: 0day (one day before transpnatation), 30 days, 90days, 180 days, 1year, 2year post transplantation
Changes in regulatory T cells in patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients.
Measured: 0day (one day before transpnatation), 30 days, 90days, 180 days, 1year, 2year post transplantation
Changes in memory T cells in patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients.
Measured: 0day (one day before transpnatation), 30 days, 90days, 180 days, 1year, 2year post transplantation
Changes in B cells in patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients.
Measured: 0day (one day before transpnatation), 30 days, 90days, 180 days, 1year, 2year post transplantation
Changes in cytokine profile in patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients.
Measured: 0day (one day before transpnatation), 30 days, 90days, 180 days, 1year, 2year post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study startSep 2013
- Primary completionSep 2016
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal Transplant RejectionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Aruna Rakha, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Aruna Rakha, PhD., Principal investigator, PGIMER, Chandigarh, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409940
- Sponsor's protocol ID
- IFA-LSBM-11
- Status last verified
- Nov 2016
- First submitted
- 24 Mar 2015
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mudrabettu C, Kumar V, Rakha A, Yadav AK, Ramachandran R, Kanwar DB, Nada R, Minz M, Sakhuja V, Marwaha N, Jha V. Safety and efficacy of autologous mesenchymal stromal cells transplantation in patients undergoing living donor kidney transplantation: a pilot study. Nephrology (Carlton). 2015 Jan;20(1):25-33. doi: 10.1111/nep.12338.
PubMed 25230334Rakha A, Todeschini M, Casiraghi F. Assessment of anti-donor T cell proliferation and cytotoxic T lymphocyte-mediated lympholysis in living donor kidney transplant patients. Methods Mol Biol. 2014;1213:355-64. doi: 10.1007/978-1-4939-1453-1_29.
PubMed 25173397
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Elucidate Effect of Mesenchymal Stem Cells on Immune Modulation in Living Related Kidney Transplant Patients
- ClinicalTrials.gov ID
- NCT02409940
- Acronym / sponsor ID
- IFA-LSBM-11
- Conditions
- Renal Transplant Rejection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Mar 2017 (estimated)
- First posted
- 7 Apr 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.
Despite being a miracle of modern medicine, solid organ transplant recipients are always at risk of rejection, and remain dependent on lifelong immunosuppression. Currently used immunosuppressive drugs suppress the potential of immune system and interfere with the metabolism of medications. Cellular therapies currently being investigated for this purpose require the use of ablative radiotherapy. The investigators are using a less toxic strategy by harnessing the immunosuppressive potential of the MSCs in the Kidney Transplant (KTx) recipients and studying immunomodulation mediated by these cells in the KTx patients.
Hypothesis MSCs interfere with signalling of Immune cells like T cells, B cells and Dendritic cells which leads to improve graft survival of renal transplant patients.
Aim To investigate effect of MSCs on immune cell repertoire in a donor specific mediated response.
The investigators aim to collect peripheral blood from 30 patients (10 patients for autologous cell infusion and 10 for allogeneic (donor derived cell infusion) at various time intervals following MSC therapy. 10 patients serve as controls on standard dose of drugs but without MSC infusion. This peripheral blood would be utilized for isolation of mononuclear cells and performing various immune assays on these cells in a donor specific response.
Detailed description
This is an open label type of study having 3 groups of patients: 1st group comprising of patients that would undergo allogeneic (donor-derived) mesenchymal stem cell infusion, 2nd group that would undergo autologous (patient-derived) mesenchymal stem cells and the third group (control group) without any stem cell infusion. All the three groups would have standard dose of Immunosuppressive drugs. Initially the investigators want to recruit 10 patients in each group and would increase the group size if the investigators get promising results on the follow up. The investigators plan to follow up the patients upto 1-2 years for immune based assays and then continue the follow up for atleast 5 years.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autologus Mesenchymal Stem Cells | Experimental | Biological: Mesenchymal Stem CellsThis group would get two doses of mesenchymal stem cell (MSCs) infusion, one day pre transplant and 30 days post transplant. These MSCs would be derived from transplant recipient's bone marrow which are cultured in GMP compliant laboratories for 4-6 weeks. |
| Allogeniec Mesenchymal Stem Cells | Active comparator | Biological: Mesenchymal Stem CellsThis group would get two doses of mesenchymal stem cell (MSCs) infusion, one day pre transplant and 30 days post transplant. These MSCs would be derived from transplant donor's bone marrow which are cultured in GMP compliant laboratories for 4-6 weeks. |
| Control without Mesenchymal Stem Cells | No intervention | –This group would get no stem cell infusion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All the renal transplant recipients participating in the trial should undergo primary kidney transplant.
- Donor should be living and related to the patient.
- Kidney transplant recipients and donor should be willing to give informed consent form.
Key exclusion criteria (3 listed)
- There should be no prior sensitization to the patients.
- Patients should not be participating in any other study
- Patients should not be suffering from any autoimmune disorders.
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 Stem CellsAlso: Mesenchymal Stromal CellsThese Mesenchymal stem cells are derived from bone marrow of either renal transplant patients or their donors depending upon the group of study. | Biological | Allogeniec Mesenchymal Stem Cells, Autologus Mesenchymal Stem Cells |
Primary outcome
Expansion of regulatory T cell compartment of the patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients.
Time frame: 6 months
Normalization of serum creatinine levels of the patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients.
Time frame: 6 months
5 secondary outcomes
T cell proliferation changes in patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients.
Time frame: 0day (one day before transpnatation), 30 days, 90days, 180 days, 1year, 2year post transplantation
Changes in regulatory T cells in patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients.
Time frame: 0day (one day before transpnatation), 30 days, 90days, 180 days, 1year, 2year post transplantation
Changes in memory T cells in patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients.
Time frame: 0day (one day before transpnatation), 30 days, 90days, 180 days, 1year, 2year post transplantation
Changes in B cells in patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients.
Time frame: 0day (one day before transpnatation), 30 days, 90days, 180 days, 1year, 2year post transplantation
Changes in cytokine profile in patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients.
Time frame: 0day (one day before transpnatation), 30 days, 90days, 180 days, 1year, 2year post transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Background: PubMed 25230334Mudrabettu C, Kumar V, Rakha A, Yadav AK, Ramachandran R, Kanwar DB, Nada R, Minz M, Sakhuja V, Marwaha N, Jha V. Safety and efficacy of autologous mesenchymal stromal cells transplantation in patients undergoing living donor kidney transplantation: a pilot study. Nephrology (Carlton). 2015 Jan;20(1):25-33. doi: 10.1111/nep.12338.
- Background: PubMed 25173397Rakha A, Todeschini M, Casiraghi F. Assessment of anti-donor T cell proliferation and cytotoxic T lymphocyte-mediated lympholysis in living donor kidney transplant patients. Methods Mol Biol. 2014;1213:355-64. doi: 10.1007/978-1-4939-1453-1_29.
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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.
Aruna Rakha, PhD. principal investigator
PGIMER, Chandigarh, India
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 Stem Cells in people with Renal Transplant Rejection, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 3 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 Nov 2016. 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 India. 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?
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?
Expansion of regulatory T cell compartment of the patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients. (time frame: 6 months). The study lists 2 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 NCT02409940, which also lists 2 linked publications.
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 Nov 2016.