We received FDA clearance for a 3 x 3, Phase 1 trial using escalating doses of the test product (autologous abdominal adipose-derived stem cells expanded and selected for their expression of Wnt). Patients were screened for age < 81 years, FAST stages 4 or 5, having a Mini Mental Status Exam (MMSE) score between 10 and 20, as well as exhibiting brain amyloid PET and CSF AD markers. The 3 patients in cohort 1 underwent: 1) liposuction, 2) Ommaya reservoir implantation, and 3) injection of the test product. Post-injection MRI, CSF, cognitive testing and Amyloid PET imaging were performed at specific intervals per protocol.

There were no serious adverse events. The injection process, required an average of 8 minutes to perform, without anesthetic. This was well-tolerated with no reported adverse events in all 3 patients, including immediate or remote headache, for at least 11 weeks (range: 11-31 weeks) post-injection. Secondary endpoints revealed CSF p-Tau decreased from a median of 60.2 pg/ml (range: 59.2-76.1) to a median of 38.6 (range 27.3-46.2) after 4 weeks. At 12 weeks, median p-Tau was reduced to a median of 33.9 (range 22.4-45.3). Pre-injection amyloid PET scan centiloid scores ranged from 138.5 to 155.5 (median, 147.0). Post-injection centiloid scores ranged from 100.5 to 104.0 (median 102.3) at 12 weeks. MMSE improved in 2 of 3 patients.