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NCT Number: NCT01429038

Mesenchymal Stem Cells After Renal or Liver Transplantation

The immune system of a patient can attack the liver or the kidney received from a donor (organ rejection). This can be prevented by treating these patients long-life with immunosuppressive drugs. Unfortunately, these drugs lead to numerous side effects and fail to prevent the rejection occurring months later after the transplantation (chronic rejection). Recently, it has been shown that a particular type of cells present in the bone marrow, namely Mesenchymal Stem Cells (MSC), when injected to a patient, suppress its immune system and increase success rates of blood cells transplantation. This outcome opens doors to investigate the potential of these cells to provide a valuable tool for improving solid organ transplantation without the need of high concentration of immunosuppressive drugs. The present project aims at evaluating the safety and tolerability of MSC administration after liver or kidney transplantation.

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Key information

Conditions

Liver Failure Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Hepatic Insufficiency Kidney Diseases Kidney Failure Liver Diseases Liver Failure, Acute Male Urogenital Diseases Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Hospital Liege

Liège, 4000, Belgium

About this study

The present project aims at evaluating the safety and tolerability of third party MSC administration after liver or kidney organ transplantation. Ten patients undergoing liver transplantation and 10 patients undergoing kidney transplantation will be included in the experimental arm to receive a single infusion of MSC. The outcome of each of these 2 subgroups will be compared with that of similar control patients undergoing liver or kidney transplantation but who will not receive MSC.

Liver and kidney transplanted patients will receive standard immunosuppressive therapy, TAC-MMF-steroïds and TAC-MMF-steroïds plus an IL-2-R antibody respectively. Patients enrolled in the experimental arms will be infused with a single dose of 1,5-3,0 10E6 MSC/kg, 3(+/-2) days after the transplantation.

Weaning of immunosuppression will be attempted from month 6 in liver transplant patients who did not present a rejection episode and show normal graft function and graft biopsy.

Kidney transplant patients will continue standard immunosuppressive therapy indefinitely.

Male or female (>18 years) individuals unrelated to the recipient or the graft donor will be MSC donors. MSC donors need to fulfill generally accepted criteria for allogeneic HSC donation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients between 18 and 75 years of age, who will undergo first Kidney Transplantation or whole Liver Transplantation from a cadaveric or donation after cardiac death (DCD) organ donor;
  • Fertile female patients must use a reliable contraception method;
  • Informed consent given by patient or his/next of kin if the patient is unable to give informed consent, for the complete (MSC + follow-up) or partial(no MSC + follow-up) study;
  • Successful liver/kidney transplantation, demonstration of organ function (improvement of INR in liver recipients and of creatinine in kidney recipients at 24-36h) and normal graft vasculature at Doppler examination.

Exclusion criteria

  • Past history of malignant disease, with the exception of hepatocarcinoma within the Milan criteria for the Liver Transplantation patients;
  • Active uncontrolled infection;
  • HIV or HCV positive;
  • EBV-negative;
  • Retransplantation;
  • Combined transplantation;
  • Living related transplantation or split liver transplantation;
  • Autoimmune disease or expected impossibility to wean immunosuppression (Liver Transplantation) or corticosteroids (Kidney Transplantation);
  • Endotracheal intubation;
  • Postoperative cardiovascular instability, active hemorrhage, or any other serious clinical complication between transplantation and evaluation for suitability for MSC infusion;
  • For Kidney Transplantation: panel reactive antibodies (PRA) >50%.

Treatment and study plan

Mesenchymal stem cells

Biological

Third party MSC 1,5-3,010E6/kg. No HLA matching between MSC donor and the recipient or the liver/kidney donor. One infusion at day 3+/-2.

Other names: MSC

Primary outcomes

  1. Infusional toxicity

    Time frame: Within 24 hours of infusion

    Incidence, timing and severity of any clinical complication related to MSC infusion, including pulmonary events or immune reactions.

  2. Incidence of infections (bacterial, viral, fungal, parasitic) and cancers

    Time frame: Continuously over 2 years

    • Incidence, timing and severity of any infection (bacterial, viral, fungal, parasitic) (blood hemoculture, urine culture, PCR CMV, PCR BK virus at month 1,2,3)
    • Incidence, timing and severity of malignant disease (Posttransplant lymphoproliferative disorder or other)

Secondary outcomes

  1. Patient and graft survivals

    Time frame: Continuously over 2 years

  2. Effects of MSC on graft function

    Time frame: over 1 year

    • Liver Transplantation: bilirubin, INR, transaminases, GGT, at day 7, months 1, 3, 6, 9, 12.
    • Kidney Transplanttaion: number of post transplant hemodialysis, creatinine at day 7, months 1, 3, 6, 9, 12.

  3. Biopsy-proven (Banff classification) rejection rates

    Time frame: over 1 year

    At months 3, 6, 9, 12.

  4. Feasibility and safety of weaning or decreasing immunosuppression

    Time frame: continuously over 2 years

    Decision points at months 3, 6, 9, 12.

  5. Recipient's immune function

    Time frame: over 1 year

    To evaluate recipient's immune function (T cell blood populations (including T regs) by FACS, TREC quantification, Vβ repertoire diversity, pathogen-specific T cells, anti-organ donor HLA antibodies).

  6. Anti-MSC donor HLA antibodies.

    Time frame: over 1 year

    To evaluate the potential development of anti-MSC donor HLA antibodies.

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

Infusion of Third-party Mesenchymal Stem Cells After Renal or Liver Transplantation. A Phase I-II, Open-label, Clinical Study

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Sep 5, 2011
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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