NCT05667649 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Duma C, Kopyov O, Kopyov A, Berman M, Lander E, Elam M, Arata M, Weiland D, Cannell R, Caraway C, Berman S, Scord K, Stemler L, Chung K, Khoudari S, McRory R, Duma C, Farmer S, Bravo A, Yassa C, Sanathara A, Singh E, Rapaport B
Human intracerebroventricular (ICV) injection of autologous, non-engineered, adipose-derived stromal vascular fraction (ADSVF) for neurodegenerative disorders: results of a 3-year phase 1 study of 113 injections in 31 patients. Mol Biol Rep. 2019 Oct;46(5):5257-5272. doi: 10.1007/s11033-019-04983-5. Epub 2019 Jul 20.

Ph 1, Open-Label Safety Study of Escalating Doses of Intracerebroventricular Injections of Ex Vivo Expanded, Autologous ADSCs in Participants With Mild-Moderate AD Whose Treatment is Not Addressed Adequately by Available Therapy

Details for clinical trial NCT05667649

Clinical trial NCT05667649 - References