Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02409940
Other study ID # IFA-LSBM-11
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received March 24, 2015
Last updated November 7, 2016
Start date September 2013
Est. completion date March 2017

Study information

Verified date November 2016
Source Postgraduate Institute of Medical Education and Research
Contact n/a
Is FDA regulated No
Health authority India: Ministry of Science and Technology
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 17
Est. completion date March 2017
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Biological:
Mesenchymal Stem Cells
These Mesenchymal stem cells are derived from bone marrow of either renal transplant patients or their donors depending upon the group of study.

Locations

Country Name City State
India Translational and Regenerative Medicine Chandigarh

Sponsors (1)

Lead Sponsor Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View Citation

Rakha 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Expansion of regulatory T cell compartment of the patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients. 6 months No
Primary Normalization of serum creatinine levels of the patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients. 6 months No
Secondary T cell proliferation changes in patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients. 0day (one day before transpnatation), 30 days, 90days, 180 days, 1year, 2year post transplantation No
Secondary Changes in regulatory T cells in patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients. 0day (one day before transpnatation), 30 days, 90days, 180 days, 1year, 2year post transplantation No
Secondary Changes in memory T cells in patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients. 0day (one day before transpnatation), 30 days, 90days, 180 days, 1year, 2year post transplantation No
Secondary Changes in B cells in patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients. 0day (one day before transpnatation), 30 days, 90days, 180 days, 1year, 2year post transplantation No
Secondary Changes in cytokine profile in patients undergoing renal transplant and infused with mesenchymal stem cells as compared to the control patients. 0day (one day before transpnatation), 30 days, 90days, 180 days, 1year, 2year post transplantation No
See also
  Status Clinical Trial Phase
Completed NCT03140514 - Urine CXCL10 Chemokine Monitoring Post-renal Transplant N/A
Completed NCT02581436 - Testing Immunosuppression Threshold in Renal Allografts To Extend eGFR N/A
Completed NCT02377193 - Simulect Versus ATG in Sensitized Renal Transplant Patient Phase 4
Completed NCT00771745 - Prospective Pilot Study of Pre-Transplant Thymoglobulin Administration in Living Donor Renal Transplant Recipients Phase 4
Not yet recruiting NCT05385432 - Induction in Sensitized Kidney Transplant Recipients Without Pre-existing Donor-specific antiboDies Phase 3
Completed NCT01953120 - Mechanisms of Belatacept Effect on Alloimmunity and Antiviral Response After Kidney Transplantation (BMS IM 103-309) Phase 4
Terminated NCT01324934 - Efficacy and Safety of ATG-Fresenius Following a Renal Transplantation, Without Corticosteroids Phase 3
Terminated NCT00983645 - A Trial Comparing Prograf and Neoral Use in Kidney Transplant Recipients of Hispanic Ethnicity Phase 4
Active, not recruiting NCT04530630 - Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide After Renal Transplant Phase 4
Recruiting NCT03707262 - Study of Combined Kidney and Blood Stem Cell Transplant From a Brother or Sister Donor Phase 1/Phase 2
Completed NCT02006108 - Imaging Kidney Transplant Rejection Using Ferumoxytol-Enhanced Magnetic Resonance N/A
Recruiting NCT03991780 - Fostamatinib in the Treatment of Chronic Active Antibody Mediated Rejection Phase 1/Phase 2
Completed NCT02733029 - Contrast Enhanced Ultrasonography to Detect Human Renal Transplant Rejection Phase 2
Active, not recruiting NCT02057965 - Mesenchymal Stromal Cell Therapy in Renal Recipients Phase 2
Completed NCT00658073 - Induction Therapy With Autologous Mesenchymal Stem Cells for Kidney Allografts N/A
Terminated NCT03646344 - Heme Arginate in Transplantation Study Phase 3
Completed NCT02866682 - Prospective Study Comparing Brand and Generic Immunosuppression on Transplant Outcomes, Adherence, & Immune Response in Kidney Transplant Recipients Phase 4
Completed NCT02500251 - Belimumab Impacting Transplant Eligibility Phase 1/Phase 2
Completed NCT00866879 - Randomized Conversion of Calcineurin-Inhibitors in Renal Allograft Recipients Phase 4
Active, not recruiting NCT03511560 - Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation Phase 4