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Determination of phenotypical and biological characteristics of mesenchymal stem cells in pediatric myelodysplastic syndromes

Recruiting
Conditions
myelodysplastic syndroom op het kinderleeftijd
bone marrow dysfunction
pre-leukemia
10024324
10027656
Registration Number
NL-OMON31742
Lead Sponsor
eids Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
45
Inclusion Criteria

Patient inclusion criteria
1 Children aged 0-18 years.
2 Patients enrolled in EWOG-MDS/JMML 2006 study.
3 Informed written consent.
Study control inclusion criteria
1 Normal fully screened donor undergoing bone marrow harvest.
2 Sufficient cells for marrow recipient.
3 Pediatric patients with de novo ANLL
4 Informed written consent.

Exclusion Criteria

Patient exclusion criteria
1 Failure of bone marrow aspirate.
2 Failure of MSC expansion;Donor control exclusion criteria
1 Insufficient harvest (cell dose below target).
2 Failure of MSC expansion.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>1. Determination for each patient and control the phenotypical and biological<br /><br>characteristics of MSC*s by flow cytometric analysis, cell culture and<br /><br>differentiation abilities.<br /><br>2. Determination of functional characteristics of MSC's isolated from<br /><br>pediatric MDS patients and controls:<br /><br>- immune regulation of T and NK cell function<br /><br>- cytokine and growth factor expression of MSC*s and the<br /><br>expression of chemokine receptor profiles<br /><br>3. Determination of cytogenetic abnormalities of MSC*s and HSC*s in MDS<br /><br>patients and controls.<br /><br>4. Determination of cell cycle control, apoptosis and differentiation by gene<br /><br>array of MSC*s and HSC*s from children with MDS and controls.<br /><br>5. Determination of MSC and CD34+ve HSC*s from MDS patients to support normal<br /><br>hematopoiesis compared to controls. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Not applicable</p><br>
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