UnknownPhase 2

Mesenchymal Stromal Cell Therapy in Renal Recipients

Netherlands70 participantsStarted 2014-03

Plain-language summary

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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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),…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fibrosis by quantitative Sirius Red scoring of MSC treated and untreated groups

Timeframe: at 6 months compared to 4 weeks post transplant

Trial details

NCT IDNCT02057965

SponsorLeiden University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01

View on ClinicalTrials.gov More Renal Transplant Rejection trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.