NewsUpdate on Overseas Regulatory Review

2022.06.30
RESEARCHES

The United States Food and Drug Administration (FDA) has informed us that the QHJI iPS cell line meets the donor eligibility requirements for clinical trials using iPS cell-derived dopaminergic progenitor cells intended for the treatment of Parkinson's disease.


Summary

The CiRA Foundation has provided the QHJI iPS cell line from its iPS cell stock to Sumitomo Pharma Co., Ltd., who has been in discussions with the FDA about a clinical trial in the United States to treat Parkinson's disease. In this trial, dopaminergic progenitor cells derived from the iPS cell line will be transplanted into patients. During the discussions, there was the realization that regulations in Japan and the United States differed regarding the requirements for using iPS cells made by the reprogramming of donor blood cells (the donor in this case is identified as QHJI). Specifically, there was concern about Title 21 CFR PRAT 1271 Subpart C - Donor Eligibility in the Code of Federal Regulations. In response, the FDA advised that QHJI should be interviewed once again and another blood sample from QHJI should be taken and tested.

Following the response of us, on April 29, 2022, the FDA granted that the iPS cells made from QHJI's blood cells fulfill the donor eligibility requirements for the proposed clinical trials using iPS cell-derived dopaminergic progenitor cells intended for the treatment of Parkinson's disease.


For HLA-homozygous iPS cells, please click here