Allogeneic Mesenchymal Stromal Cell Therapy in Renal Transplant Recipients (Neptune)
|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: NCT02387151|
Recruitment Status : Active, not recruiting
First Posted : March 12, 2015
Last Update Posted : March 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rejection Graft Loss||Drug: mesenchymal stromal cells||Phase 1|
Kidney transplantation has improved survival and quality of life for patients with end-stage renal disease. However, despite advances in immunosuppressive therapy, long-term allograft survival outcomes have not improved over the last decade.
A promising novel therapeutic immunosuppressive option in the treatment of renal recipients with a profound effect on the fibrosis reaction is the clinical application of mesenchymal stromal cells (MSCs). Allogeneic MSCs offer the advantage of availability for clinical use without the delay required for expansion.
Although it is believed that allo MSCs are immune privileged, they could possibly elicit an anti-donor immune response, which may increase the incidence of rejection/ graft loss and impact the allograft survival on the long term. These safety issues should be studied before further studies are planned with allogeneic MSCs in the transplant setting.
MSCs are infused at a time point when immune suppression is lowered and the kidney is at increased risk for developing immune mediated injury. In addition, a large amount of the kidneys already has signs of fibrosis at this time point and MSCs might reduce the fibrosis which so importantly affects long term survival. MSCs will have no Human Leucocyte Antigen (HLA) sharing with the mismatches of the donor and the recipient should have no antibodies directed to the MSCs to reduce the anti-donor immune respons risk.
|Study Type :||Interventional|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety of Allogeneic Bone Marrow Derived Mesenchymal Stromal Cell Therapy in Renal Transplant Recipients|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
Experimental: mesenchymal stromal cells
allogeneic mesenchymal stromal cell infusion
Drug: mesenchymal stromal cells
2 doses of 1-2x10^6 allogeneic bone marrow derives MSCs IV per/kg body weight at weeks 25 and 26 after transplantation
- biopsy proven acute rejection / graft loss [ Time Frame: 12 months after transplantation ]
- Comparison of fibrosis by quantitative Sirius Red scoring [ Time Frame: Before MSC infusion (week 24 after transplantation) and 6 months after MSC infusion (week 52 after transplantation) ]
- Serious adverse events [ Time Frame: 12 months after transplantation ]
- Renal function measured by cGFR (MDRD formula) and iohexol clearance [ Time Frame: week 24 after transplantation (before MSC infusion) and 52 after transplantation ]
- CMV, BK infection (viremia, disease and syndrome; and subtypes of BK viremia) and other opportunistic infections [ Time Frame: from baseline up to 26 weeks after MSC treatment ]
- Development of de novo donor specific antibodies (DSA) and immunological responses [ Time Frame: at baseline, week 24 after transplantation (before MSC treatment) up to week 26 after MSC treatment ]
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): NCT02387151
|Leiden University Medical Center|
|Leiden, Netherlands, 2333 ZA|
|Principal Investigator:||Marlies EJ Reinders, MD/PhD||Leiden University Medical Center|