Focal Segmental Glomerulosclerosis Clinical Trial
Official title:
Allogenic Adipose Derived Mesenchymal Stromal Cells Transplantation to Improve Kidney Function in Refractory Primary Nephrotic Syndrome (Focal Segmental Glomerulosclerosis,FSGS) ,a Phase I Clinical Trial
Idiopathic Focal Segmental Glumero Sclerosis (FSGS) is not very common but important
manifestation of kidney disease.
FSGS has poor prognosis among the patterns of Idiopathic Nephrotic Syndrome (INS).
Even with treatment (Steroid therapy and cytotoxic immunosuppressant therapy), many patients
eventually still require dialysis.
Cell therapy is useful in treatment of INS and mesenchymal stromal/stem cell is one of the
cells that useful in the treatment of glomerulus disease.
Intravenous injection of allogeneic adipose derived mesenchymal stromal/stem cell will be
done in 5 patients with refractory INS(FSGS). They will be followed 1, 2, 4 weeks and then
monthly until a year following injection day.
Primary FSGS thought to be a part of the immune-mediated disease. Main challenge is to
decrease protein excretion in urine. Only 30% of children with FSGS achieve complete
remission with steroids and other 30-40% patients experience remission (partial and
complete) with cytotoxic immunosuppressant drugs. Even with these treatments, many patients
eventually still require dialysis. Other treatment strategy doesn't exceed beyond
symptomatic treatment and delaying the progression. Also risk of recurrence after kidney
transplantation is 20-50%.
Cell therapy is one of the treatment strategies and mesenchymal stromal/stem cell is one
modality that notice in glomerulus disease.
We will evaluate safety and efficacy of intravenous injection of allogeneic AD-MSC
(adipose-derived mesenchymal stromal cell) in 5 refractory INS patients.They will be
followed 1, 2, 4 weeks and then monthly until a year following injection day.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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