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Intra-marrow transplantation of Mesenchymal Stromal Cells to treat MyeloDysplastic Syndromes: A feasibility study

Intra-marrow transplantation of Mesenchymal Stromal Cells to treat MyeloDysplastic Syndromes: A feasibility study - PMDS28 / Intra-marrow transplantation of Mesenchymal Stromal Cells in MDS

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37006
Enrollment
29
Registered
2012-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic syndromes

Interventions

Nine patients (classic 3x3 design) will participate in the phase I part and receive increasing doses of MSCs directly infused in the bone marrow cavity of the left or right spina iliaca post (intra-

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Subjects with a cytopathologically confirmed diagnosis of (a) Patients with MDS RCUD, MDS RARS, MDS RCMD, MDS RAEB-1 and an IPSS * 1 (appendix C) (b) An indication for treatment: patients should have had at least one red blood cell (RBC) transfusion in the two months prior to inclusion due to a hemoglobin level

Exclusion criteria

Exclusion criteria: * MDS RCUD, MDS RARS, MDS RCMD, MDS RAEB-1 and an IPSS * 1 and erythropoietin level 2.5 x normal value * Bilirubin > 2 x normal value * Serum creatinin > 2 x normal value (after adequate hydration) * Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.) * Cardiac dysfunction as defined by: * Myocardial infarction within the last 6 months of study entry, or * Reduced left ventricular function with an ejection fraction

Design outcomes

Primary

MeasureTime frame
* The safety of intra-marrow transplantation of MSCs in low and int-1 risk IPSS MDS patients.—

Secondary

MeasureTime frame
* Efficacy (CR, PR, Hematological Improvement, SD, PD) 3 months after intra-marrow MSC infusion * Efficacy (CR, PR, Hematological Improvement, SD, PD) 12 months after intra-marrow MSC infusion * Overall survival measured from the date of first MSC infusion * Probability of progression to AML after intra-marrow MSC infusion * Number and duration of hospitalization as well as transfusion requirements (red cell and platelet transfusion). * Cytogenetic responses in CD34+ and CD45- cell fractions determined by FISH analyses * Determination of prognostic factors on response. * Adverse events—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)