MESENCHYMAL STROMAL CELLS (MSC) have shown promising albeit not always consistent therapeutic effects in the treatment of severe steroid-resistant acute Graf versus Host Disease. Remarkably, in all reported clinical studies the toxicity of Mesenchymal stromal cells administration has been found consistently negligible. The investigators believe that Umbilical Cord (UC) derived Mesenchymal stromal cells may represent a stronger immunosuppressive tool for such clinical emergency and no data suggest any change in the safety profile of these cells. For this reason, and in the best interest of the patient, the investigators plan to test the safety and activity of Umbilical Cord Mesenchymal stromal cells when given sequentially to another partially effective treatment of steroid resistant acute graf versus host disease such as Pentostatin.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
pentostatin, dose 1 mg/m2 § MSC doses: 1. 3 patients → 3 infusions of 1x106 cells /kg 2. 3 patients → 3 infusions of 2x106 cells /kg 3. 3 patients → 3 infusions of 3x106 cells /kg
A O Papa Giovanni XXIII
Bergamo, Italy
RECRUITINGAo S Croce E Carle
Cuneo, Italy
RECRUITINGAO Careggi
Florence, Italy
NOT_YET_RECRUITINGIRCCS G Gaslini
Genova, Italy
NOT_YET_RECRUITINGFondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, Italy
ACTIVE_NOT_RECRUITINGClinica Pediatrica San Gerardo
Monza, Italy
ACTIVE_NOT_RECRUITINGAzienda Ospedaliero-Universitaria Di Udine
Udine, Italy
NOT_YET_RECRUITINGOspedale San Bortolo
Vicenza, Italy
RECRUITINGvital parameters
Following infusion of UC-MSC, the patient will be monitored for acute infusion-related toxicity. Any toxicity will be treated at the discretion of the attending physician. Infusional toxicity is defined as any alteration of the vital parameters of the patient if they have appeared acutely and may be directly correlated to the UC-MSC infusion
Time frame: one year
assessed of acute graft versus host disease (GvHD)
graft versus host disease will be assessed at day +7, +9, +12, +14, +16, +19, +21, +28, + 35, +42 e +49 and after 6 months and 1 year from the last UC-MSC infusion. Efficacy on acute graft versus host disease is defined as complete or partial resolution of acute GvHD evaluated according to conventional staging and grading score systems.The efficacy will be evaluated at day +30 after the third UC-MSC infusion or, if less, at day +30 after the last UC-MSC infusion.
Time frame: one year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.