- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00696046
Intra Bone Marrow Injection Of Unrelated Cord Blood Cells (CB01)
Direct Intra Bone Marrow Injection Of Unrelated Cord Blood Cells To Improve Engraftment And Reduce Acute Graft-Versus-Host Disease
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Study Design Phase I-II study. Neutrophil recovery > 80% at day 60 and Platelets recovery > 80% at days 100 are defined as success. The limit of 60 days for neutrophil recovery was chosen because it represents the time at which rescue with a second transplant is decided in case of failure to engraft; the day 100 for platelets recovery is taken corresponds to first form reported after transplant to the European Blood and Marrow Transplant Registry.
HLA-A and -B antigens will be identified by low resolution DNA typing, whereas HLA-DRB1 type was determined by high resolution DNA typing techniques. HLA-A, HLA-B, and HLA-DRB1 typing was used to select the most closely matched donor unit-recipient pair, with preference given to HLA-DRB1-matched unit
Studietype
Registrering (Forventet)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: francesco Frassoni, MD
- Telefonnummer: 3941 +39 010 5553961
- E-post: francesco.frassoni@hsanmartino.it
Studiesteder
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Genoa, Italia, 16132
- Rekruttering
- A.O. San Martino - Dep. Center Stem cells and cell therapy"
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Hovedetterforsker:
- francesco frassoni, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients with hematologic malignancies and other forms of hematologic diseases including aplastic anemia
- Patients will be eligible to enter the study when: A) an unrelated stem cell transplantation was indicated; b) no suitable unrelated HLA-matched donors will be identified in a clinically useful time-frame.
- Age 16-70
- Serum creatinine <1.5 mg/dL or Creatinine Clearance >50 ml/min
- Serum bilirubin <1.5 mg/dl, SGPT <3 x upper limit of normal
- Negative serology for HIV
- Central Venous access (Central KT) secured through an indwelling catheter.
- Life expectancy is not severely limited by concomitant illness.
- Written and signed informed consent
Exclusion Criteria:
- Acute Myocardial Infarction (AMI) within the last 12 months
- Positive pregnancy test
- Positive HIV serology
- Chronic renal insufficiency (Serum creatinine >1.5 mg/dl or creatinine cleareance <=50 ml/min)
- Patient has another progressive malignant disease or a history of other malignancies within 2 years prior to study entry.
- Severe psychiatric illness or any disorder that compromises ability to give truly informed consent for participation in this study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
the safety and the probability of neutrophils and platelets recovery after i.b. cord blood transplant.
Tidsramme: Full blood count, Monitoring Infections post Transplant, Bone marrow evaluation, Chimerism Analysis, Haematopoietic Reconstitution
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Full blood count, Monitoring Infections post Transplant, Bone marrow evaluation, Chimerism Analysis, Haematopoietic Reconstitution
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
the incidence/severity of acute Graft-versus-Host Disease, relapse and overall survival.
Tidsramme: Graft-versus-host disease was scored according to current criteria (13).
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Graft-versus-host disease was scored according to current criteria (13).
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: francesco frassoni, MD, A.O. San martino
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CB01-139
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