ClinicalTrials.gov
ClinicalTrials.gov Menu

To Elucidate the Effect of Mesenchymal Stem Cells on the T Cell Repertoire of the Kidney Transplant Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02409940
Recruitment Status : Active, not recruiting
First Posted : April 7, 2015
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Aruna Rakha, Postgraduate Institute of Medical Education and Research

Brief 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.


Condition or disease Intervention/treatment Phase
Renal Transplant Rejection Biological: Mesenchymal Stem Cells Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized Trial to Elucidate Effect of Mesenchymal Stem Cells on Immune Modulation in Living Related Kidney Transplant Patients
Study Start Date : September 2013
Actual Primary Completion Date : September 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Autologus Mesenchymal Stem Cells
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.
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.
Other Name: Mesenchymal Stromal Cells

Active Comparator: Allogeniec Mesenchymal Stem Cells
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.
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.
Other Name: Mesenchymal Stromal Cells

No Intervention: Control without Mesenchymal Stem Cells
This group would get no stem cell infusion.



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02409940


Locations
India
Translational and Regenerative Medicine
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Aruna Rakha, PhD. PGIMER, Chandigarh, India