Fibrosis Clinical Trial
— MSCsOfficial title:
Autologous Bone Marrow Derived Mesenchymal Stromal Cell Therapy in Combination With Everolimus to Preserve Renal Structure and Function in Renal Recipients
Verified date | September 2020 |
Source | Leiden University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will test the hypothesis that MSCs in combination with Everolimus facilitate Tacrolimus withdrawal, reduce fibrosis and decrease the incidence of opportunistic infections compared to standard tacrolimus dose.
Status | Active, not recruiting |
Enrollment | 70 |
Est. completion date | January 2022 |
Est. primary completion date | January 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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. - Recipients of a first kidney graft from a deceased, living-unrelated or non-HLA identical living related donor > 50 years of age. - Panel Reactive Antibodies (PRA) = 10%. - Patients must be able to adhere to the study visit schedule and protocol requirements. - If female and of child-bearing age, subject must be non-pregnant, non-breastfeeding, and use adequate contraception. Exclusion Criteria: - Double organ transplant recipient. - Biopsy proven acute rejection (according to the Banff criteria) in the first 6 weeks after transplantation. - Patients with evidence of active infection or abscesses (with the exception of an uncomplicated urinary tract infection) before MSC infusion. - Patients suffering from hepatic failure. - Patients suffering from an active autoimmune disease. - Patients who have had a previous BM transplant. - A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study. - Use of any investigational drug after transplantation. - Documented HIV infection, active hepatitis B, hepatitis C or TB according to current transplantation inclusion criteria. - 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. - 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. - Known recent substance abuse (drug or alcohol). - Contraindications to undergo a BM biopsy. - Patients who are recipients of ABO incompatible transplants. - Cold ischemia time >30 hrs. - Patients with severe total hypercholesterolemia (>7.5 mmol/L) or total hypertriglyceridemia (>5.6 mmol/L) (patients on lipid lowering treatment with controlled hyperlipidemia are acceptable). |
Country | Name | City | State |
---|---|---|---|
Netherlands | Leiden University Medical Center | Leiden |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center |
Netherlands,
Reinders ME, de Fijter JW, Roelofs H, Bajema IM, de Vries DK, Schaapherder AF, Claas FH, van Miert PP, Roelen DL, van Kooten C, Fibbe WE, Rabelink TJ. Autologous bone marrow-derived mesenchymal stromal cells for the treatment of allograft rejection after — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fibrosis by quantitative Sirius Red scoring of MSC treated and untreated groups | at 6 months compared to 4 weeks post transplant | ||
Secondary | Renal function and proteinuria | 6 months | ||
Secondary | Number of participants with CMV and BK infection an other opportunistic infections between groups | 6 months | ||
Secondary | Number of participants with adverse events | 6 months | ||
Secondary | composite end point efficacy failure (biopsy proven acute rejection, graft loss or death) | 6 months | ||
Secondary | Presence of donor specific antibodies and immunologic monitoring | 6 months | ||
Secondary | Progression of subclinical cardiovascular disease in the different treatment groups bij assessing echocardiographic parameters | 6 months |
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