| Eligibility |
Inclusion Criteria:
1. Minimum 18 years of age who have undergone hematopoietic cell transplantation (HCT),
from any donor source donor (including HLA-matched related and unrelated,
haploidentical and umbilical cord donors) with any conditioning regimen
2. Clinically diagnosed Grades II to IV acute GVHD as per standard criteria occurring
within 100 days of HCT
3. Confirmed diagnosis of steroid refractory aGVHD defined as patients administered
high-dose systemic corticosteroids (methylprednisolone 2 mg/kg/day [or equivalent
prednisone dose 2.5 mg/kg/day]), given alone or combined with calcineurin inhibitors
(CNI) and either:
1. Progressing based on organ assessment after at least 3 days at the time of
initiation of high-dose systemic corticosteroid +/- CNI for the treatment of
Grade II-IV aGVHD, OR
2. Failure to achieve at a minimum partial response based on organ assessment after
7 days compared to organ stage at the time of initiation of high-dose systemic
corticosteroid +/- CNI for the treatment of Grade II-IV aGVHD, OR
3. Patients who fail corticosteroid taper defined as fulfilling either one of the
following criteria:
i. Requirement for an increase in the corticosteroid dose to methylprednisolone =2
mg/kg/day (or equivalent prednisone dose =2.5 mg/kg/day), OR
ii. Failure to taper the methylprednisolone dose to <0.5 mg/kg/day (or equivalent
prednisone dose <0.6 mg/kg/day) for a minimum 7 days.
4. Minimum Karnofsky Performance Level of at least 30 or higher at the time of study
entry.
Exclusion Criteria:
1. Has received more than one systemic treatment for steroid refractory aGVHD in addition
to steroids.
2. Received stem cell therapy in the past
3. Presence of an active uncontrolled infection including significant bacterial, fungal,
viral, or parasitic infection requiring treatment
4. Presence of relapsed primary malignancy, or who have been treated for relapse after
the HCT was performed, or who may require rapid immune suppression withdrawal as
pre-emergent treatment of early malignancy relapse.
5. Evidence of pulmonary infiltrate or hemorrhage based on imaging or requiring high flow
oxygen via face mask
6. Patients who have had treatment with any other investigational agent, device, or
procedure within 30days (or 5 half-lives, whichever is greater) prior to enrollment.
7. Patients who have received more than one HCT
8. Any medical or psychological condition or situation deemed by the Investigators to put
the patient at increased risk of complications or non-compliance.
9. Unresolved veno-occlusive disease
10. HLA antibody screen positive for HLA antibodies specific against the MSCs products
11. ALT or AST > 5X of upper limit of normal
12. Serum Bilirubin >2 X of upper limit of normal
13. GFR <50 ml/min
14. SpO2 <94% despite being on continuous supplemental oxygen
15. Patients requiring continuous >4L/minute of supplemental oxygen (irrespective of
oxygen saturation)
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