https://bio.nikkeibp.co.jp/atcl/news/p1/24/03/29/11755/

The company filed a clinical trial application (IND) in February 2024, and recently completed a 30-day investigation by the U.S. Food and Drug Administration (FDA).

This corporate clinical trial uses frozen allogeneic iPS cell-derived dopaminergic neural progenitor cells. Allogeneic iPS cells will be induced to differentiate at Sumitomo Pharma’s regenerative and cell therapy manufacturing plant (SMaRT), then frozen and airlifted to the United States. DSP-1083 will then be shipped to the medical institution on the day of the surgery. Although the company has not made this public, it is likely that they are using allogeneic iPS cells provided by the Kyoto University iPS Cell Research Foundation (iPS Foundation).

This corporate clinical trial will be conducted as a multi-center, double-blind, randomized trial at the Phase 1/2 stage. Several dozen patients will be divided into a treatment observation group and a sham observation group. Sumitomo Pharma America, the company’s US subsidiary, will lead the clinical trial.

The end date of the corporate clinical trial has not yet been determined, but the observation period will be two years. The primary endpoint is safety, which measures the frequency and severity of adverse events. Secondary endpoints include evaluation of motor symptoms and other efficacy measures.