Cell Therapy LLC
The purpose of this study is to assess the safety and tolerability of intrathecal administration of CE-1 at a weight-based dose (cells/kg BW), capped at a maximum total dose of 1×10⁸ cells in 10 mL, with administered volume calculated using M = 0.167 mL/kg BW. Study details include: The overall study duration will be up to three years. The primary endpoint will be assessed at 6 months following investigational product administration. An additional secondary endpoint will be assessed at 12 months in the form of a phone call. Study visits therefore consist of one interventional visit, an evaluation visit within two weeks post-injection, a primary endpoint follow-up visit at 6 months, and a secondary endpoint follow-up phone call at 12-months.
Inclusion Criteria: 1. Once the voluntary nature of the study is explained in detail, the participant must be willing to provide written informed consent and complete HIPAA documentation before conducting any study-related procedure. A signed written informed consent and ability to comply with the study protocol according to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and local regulations is required. 2. Male or female aged 18 years and older at the time of enrollment 3. Females of childbearing potential must have a negative pregn…
A weight-based intrathecal dose
Arctuva estimate
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