Stem cell transplantation with stem cells from related and non-related donators in pediatric patients with and without malignant diseases.

Phase 1

• Conditions: Pediatric patients with malignant and non-malignant high-risk diseases, where the allogeneic stem cell transplantation represents the only option for a curative therapy and where an adequate HLA-identical donator is not available.; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2006-000393-76-DE
• Lead Sponsor: Johann Wolfgang Goethe-Universität Frankfurt am Main

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-21
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Patients age between 0 and 30 years
Written informed consent from the patient or from at least one of the patient’s parents (person having the care and custody of the child)
Patients with a Karnofsky Index > 60%
A malignant disease:
acute lymphatic leucemia
acute myeloic leucemia
myelodysplastic syndrome
chronic myeloic leucemia according to the standard indications
Solid Tumors (e.g. relapse of a neuroblastom, soft tissue sarcoma, Ewing sarcoma, osteo sarcoma, hepatoblastome
Or a non-malignant disease:
Acquired anemia (e.g. severe aplastic anemia, in particular the severe form of the Evans syndrome)
congenital anemia (e.g. thalassemia; sickle cell anemia)
A reliable contraception has to be observed in sexual reproductive women
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patient or responsible person (person having the care and custody of the child), who is not able to understand the character and implications of this clinical trial
Pregant or breast-feeding women
Patients with a prior history of a stem cell transplantation within the last 250 days
Renal, cardiac or hepatic insufficiency

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified