Bone marrow derived mesenchymal stem cells for the treatment of allograft rejection after renal transplantatio

Completed

• Conditions: aandoeningen na niertransplantatie; allograft rejection; rejection after (renal) transplantation; 10038430

• Registration Number: NL-OMON31649
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1. Female or male, aged between 18 and 65 years.
2. Subject is willing to participate in the study and has signed the informed consent.
3. Recipents of a first kidney graft from a living HLA-DR mismatched donor (2 HLA-DR mismatches).
4. Subjects included in the study must have kidney biopsy proven SCR 4 weeks after transplantation.
5. Patients must be on triple immunosuppressive therapy of prednisone, CsA or tacrolimus and MMF according to current protocol.
6. Panel Reactive Antibodies (PRA) <= 5%.
7. Patients must be able to adhere to the study visit schedule and protocol requirements.
8. If female and of child-bearing age, subject must be non-pregnant, non-breastfeeding, and use adequate contraception.
9. Patients must be able to give informed consent and the consent must be obtained prior to any study procedure.

Exclusion Criteria

1. Double organ transplant recipient.
2. Acute clinical rejection after transplantation.
3. Patients with evidence of active infection or abcesses before MSC infusion.
4. Patients suffering from hepatic failure.
5. Patients suffering from an active autoimmune disease.
6. Patients who have had a previous BM transplant.
7. A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study.
8. Use of any investigational drug after transplantation.
9. Documented HIV infection, active hepatitis B, hepatitis C or TB according to current transplantation inclusion criteria.
10. Subjects who currently have an active opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus (CMV), Pneumocystis carinii (PCP), aspergillosis, histoplasmosis, or mycobacteria other than TB) after transplantation.
11. 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.
12. Known recent substance abuse (drug or alcohol).
13. Contraindications to undergo a BM biopsy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1 Safety: rate of (serious) adverse events in the study population using the<br /><br>World Health Organization (WHO) criteria.<br /><br>2 Feasibility: determination of the number of expanded MSCs in relation to the<br /><br>amount of BM collected, number of passages required and time to reach study<br /><br>target doses.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1 Presence of late acute rejection in the 6 month biopsy compared with the 4<br /><br>week biopsy.<br /><br>2 Sirius red staining for renal cortical matrix accumulation in the 6 month<br /><br>biopsy compared with the 4 week biopsy.<br /><br>3 Immunologic response (immunologic properties of peripheral blood T cells<br /><br>before and after MSC infusion) after 6 months. </p><br>