Treatment of steroid resistant grade II to IV acute GVHD by infusion of mesenchymal stem cells expanded with human plasma and platelet lysate ; a phase I/II study - MSC for resistant GVHD

• Conditions: MSCs may be useful for treating established severe GVHD after stem cell transplantation. Preliminary data on 40 patients with steroid refractory grade III-IV acute GvHD were recently presented (K Leblanc; European Blood and Marrow Transplantation group, Lyon, march 2007). Among the forty patients treated, nineteen had complete responses, nine showed improvement and seven patients did not respond. There was no apparent correlation between the response and the dose of MSCs given.

• Registration Number: EUCTR2007-003341-32-NL
• Lead Sponsor: niversity medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-26
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. For screening and MSC culture: newly diagnosed acute grade II-IV GVHD or chronic GVHD with an acute pattern matching grade II-IV after allogeneic stem cell transplantation
2. For infusion: steroid refractory grade II-IV acute GVHD or chronic GVHD with an acute pattern matching grade II-IV after allogeneic stem cell transplantation.
3. Patients must have received 2 mg/kg/day of prednisolon for at least 3 consecutive days and experience progression of GVHD or no response to at least 7 days of steroid treatment.
4. In addition to steroids the patient has received either cyclosporin (trough level 150-250 ng/ml) or tacrolimus (trough level 5-15 ng/ml). Patients with steroid refractory GvHD may be treated with second line therapy according to the clinical practice at the center while waiting for MSC infusion. At each center all patients included in the study should be treated in the same way.
5. Written informed consent.

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

1. Patients with poor performance, not expected to survive 3 weeks.
2. Donor Chimerism below 90%
3. Active uncontrolled CMV, EBV or fungal infection

Study & Design

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