Induction Therapy With Autologous Mesenchymal Stem Cells for Kidney Allografts
7. mars 2011 oppdatert av: Fuzhou General Hospital
Autologous Bone Marrow Mesenchymal Stem Cell Transplantation in Recipients of Living Kidney Allografts
The goal of this study is to evaluate autologous MSCs as an alternative for antibody induction therapy in renal transplantation.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Renal transplantation is the most common and successful type of organ transplantation.
Induction therapy with antibody plus the maintenance immunosuppressive agents have greatly improved graft survival in renal transplantation.
Since mesenchymal stem cells(MSCs)have been used successfully to treat graft versus host disease and show immune modulation function both in vitro and in vivo and may help in repairing damaged tissue(s), we evaluate autologous MSCs as an alternative for antibody induction therapy.
Moreover, we examine if MSCs could improve the recovery of early function in transplanted kidney.
Studietype
Intervensjonell
Registrering (Faktiske)
165
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Fujian
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Fuzhou, Fujian, Kina, 350025
- Stem cell therapy center,Fuzhou General Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 60 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patients must be between the ages of 18 and 60 years and meet the institution's criteria for renal transplantation for end-stage renal failure
- Patient is receiving the first renal transplant
- Patient is receiving a renal transplant only
- Women who are of child bearing potential must have a negative pregnancy test (urine test is acceptable) and agree to use reliable contraception for 1 year following transplant
- Willing to comply with the study visits
- Be able to sign informed consent document.
Note: The subjects do not need to be local residents in order to be eligible for this trial, but must be willing to reside in the area, or within a four hour drive, for the first three months of the protocol so that we can monitor them closely in the early post transplant period.
Exclusion Criteria:
- Previously received or is receiving an organ transplant other than a kidney
- Significant liver disease, defined as having continuously elevated AST (SGOT) or ALT (SGPT) levels greater than 3 times the upper value of the normal range within 28 days prior to study entry
- HIV infection.
- Surface antigen positive for HBV.
- Antibody positive for hepatitis C virus
- Recipient or donor is positive for tuberculosis (TB), under treatment for suspected TB, or previously exposed to TB
- Currently receiving an investigational drug or received an investigational drug within 30 days prior to transplant.
- Currently receiving any immunosuppressive agent.
- Clinically active bacterial, fungal, viral or parasitic infection
- Evidence for immunologic memory against donor.
- Recipients need antibody induction treatment before the operation.
- Current cancer or a history of cancer within the 5 years prior to study entry.
- Serious heart and lung diseases.
- Patients who's RPR is positive
- Pregnancy or breastfeeding.
- Have no ability to communicate.
- Any form of substance abuse, psychiatric disorder, or other condition that, in opinion of the investigator, may interfere with the study
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: A
Patients in Group A will receive MSCs instead of anti-interleukin 2 receptor antibody for induction therapy.
The first MSCs infusion intravenously will be right at releasing renal artery clamp to establish allograft blood flow and the second infusion of MSCs will be performed two weeks after transplantation.
Patients will receive standard regular immunosuppressive agents including calcineurin inhibitor, glucocorticoid, and MMF.
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Patients in Group A will receive the first MSCs infusion intravenously within 24 hours after kidney transplant operation , and the second infusion of MSCs will be performed two weeks later.
Andre navn:
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Aktiv komparator: B
Patients in Group B will receive MSCs instead of anti-interleukin 2 receptor antibody for induction therapy.
The first MSCs infusion intravenously will be right at releasing renal artery clamp to establish allograft blood flow and the second infusion of MSCs will be performed two weeks after transplantation.
Patients will receive 80% less of calcineurin inhibitor than in Group A. Other immunosuppressive agents such as glucocorticoid and MMF remained the same doses as in Group A.
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Patients in Group A will receive the first MSCs infusion intravenously within 24 hours after kidney transplant operation , and the second infusion of MSCs will be performed two weeks later.
Andre navn:
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Aktiv komparator: C
Patients in Group C will receive anti-interleukin 2 receptor antibody (Basiliximab)for induction therapy.
Patients will receive the same doses of regular immunosuppressive agents including calcineurin inhibitor, glucocorticoid, and MMF as in Group A.
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kidney transplantation with standard immunosuppressive treatment regime
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Incidence rate of biopsy-proven acute rejection and early renal function recovery
Tidsramme: At 1 year post-transplant
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At 1 year post-transplant
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Patient and graft survival and prevalence of adverse events
Tidsramme: At 1 year post-transplant
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At 1 year post-transplant
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Jianming Tan, M.D and Ph.D, Fuzhou General Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mars 2008
Primær fullføring (Faktiske)
1. september 2010
Studiet fullført (Faktiske)
1. oktober 2010
Datoer for studieregistrering
Først innsendt
8. april 2008
Først innsendt som oppfylte QC-kriteriene
11. april 2008
Først lagt ut (Anslag)
14. april 2008
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
8. mars 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. mars 2011
Sist bekreftet
1. februar 2011
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- MSC-K-2
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