NL-OMON31471
Withdrawn
Phase 2
Infusion of mesenchymal stem cells as treatment for steroid resistant grade II to IV acute GVHD or poor graft function: a multicenter phase II study - Mesenchymale stem cells versus acute GVHD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- mesenchymale stamcellen bij acute GvHD of onvoldoende functionerende greffe
- Sponsor
- Academisch Ziekenhuis Maastricht
- Enrollment
- 10
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient eligibility criteria
- •\-male or female of any age
- •\-previous allogenic transplantation (related or unrelated donor, any degree of HLA matching) or autologous transplantation (for oart two only) or HSC at any time before.
- •\- any source of HSC (marrow, PBSC, cord blood) and any conditioning regimen
- •\- informed consent given by donor or his/her guardian if of minor age;MSC donor inclusion criteria
- •1\. related to the recipent (sibling, parent or child) or unrelated
- •2\. male or female
- •3\. age\> 16 yrs (no age limit if same as HSC donor)
- •4\. no HLA matching required
- •5\. fulfills generally accepted criteria for allogeneic HSC donation
Exclusion Criteria
- •\- HIV postive
- •\- active uncontrolled infection at time of scheduled MSC infusion
- •\- relapsing or progressing malignancy;MSC donor exclusion criteria
- •1\. HIV positive
- •2\. known allergy to lidocaine
- •3\. if donor other than HSC donor: any risk factor for transmissible infectious diseases
Outcomes
Primary Outcomes
Not specified
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