A phase 1 multicentre open label dose-escalation study of unrelated, major histocompatibility (MHC)-unmatched mesenchymals stem cells (MSC) for the treatment of steroid refractory acute graft versus host disease in recipients of allogeneic heamatopoietic stem cell transplants

Inclusion Criteria13

• Patient is willing and has received an allogeneic bone marrow transplant for a life-threatening disease
• Patient has steroid-refractory graft-versus-host disease following the allogeneic bone marrow transplant
• Patient or guardian must furnish written informed consent.
• Adequate cardiac function with a left ventricular ejection fraction > 45% of predicted.
• Adequate pulmonary function pre-haematopietic stem cell transplant, as defined as no severe or symptomatic restrictive or obstructive lung disease, and pulmonary function testing showing an forced expired volume in one second (FEV1) >50% of predicted and a carbon monoxide diffusin capacity (DLCO) >50% of predicted.
• (Children less than 6 years of age must have normal oxygen saturation, in the opinion of the Investigator)
• Adequate renal function as defined by a creatinine clearance >40% of normal.
• Adequate hepatic function as defined by a total bilirubin < 2x normal except for patients with hepatic dysfunction thought due to graft versus host disease.
• Adequate neurological function as defined by no evidence of a severe central or peripheral neurological abnormality.
• Adequate immunologic function as defined by no evidence of active infection at the time of the transplant preparative regimen.
• Female patients are not pregnant, not breast-feeding and are using adequate birth control technique
• Patient must be human immunodeficiency virus (HIV)-1 & 2 antibody sero-negative
• Patient must demonstrate ability to be compliant with medical regimen.