Safety of allogeneic bone marrow derived mesenchymal stromal cell therapy in renal transplant recipients
- Conditions
- fibrosisrejection10038430
- Registration Number
- NL-OMON40295
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
1.Female or male, aged between 18 and 75 years.
2.Subject is willing to participate in the study, must be able to give informed consent and the consent must be obtained prior to any study procedure.
3.Recipients of a first kidney graft from a living-unrelated or non-HLA identical living related donor.
4.Panel Reactive Antibodies (PRA) <= 50%.
5.Patients must be able to adhere to the study visit schedule and protocol requirements.
6.If female and of child-bearing age, subject must be non-pregnant, non-breastfeeding, and use adequate contraception.
1. Double organ transplant recipient.
2. Biopsy proven acute rejection (according to the Banff criteria) in the 4 weeks before MSC infusion.
3. Patients with evidence of active infection or abscesses (with the exception of an uncomplicated urinary tract infection) before MSC infusion.
4. Patients suffering from hepatic failure.
5. Patients suffering from an active autoimmune disease.
6. A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study.
7. Use of any investigational drug after transplantation.
8. Documented HIV infection, active hepatitis B, hepatitis C or TB according to current transplantation inclusion criteria.
9. Subjects who currently an active opportunistic infection at the time of MSC infusion (e.g., herpes zoster [shingles], cytomegalovirus (CMV), Pneumocystis carinii (PCP), aspergillosis, histoplasmosis, or mycobacteria other than TB, BK) after transplantation.
10. Malignancy (including lymphoproliferative disease) within the past 2-5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence) according to current transplantation inclusion criteria.
11. Known recent substance abuse (drug or alcohol).
12. Patients who are recipients of ABO incompatible transplants.
13. Patients with severe total hypercholesterolemia (>7.5 mmol/L) or total hypertriglyceridemia (>5.6 mmol/L) (lipid lowering treatment with controlled hyperlipidemia is acceptable).*
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary end point is safety by assessing the composite end point of<br /><br>BPAR/graft loss after MSC treatment. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Comparison of fibrosis by quantitative Sirius Red scoring at 52 weeks compared<br /><br>to 24 weeks post-transplant; de novo HLA antibody development by luminex<br /><br>(including C1q binding) before and after MSC infusions; renal function measured<br /><br>by cGFR (MDRD formula); CMV and BK infection (viremia, disease and syndrome and<br /><br>subtype of BK) and other opportunistic infections; immune monitoring after MSC<br /><br>treatment</p><br>