Landmark 76 · Trial in people
Aspen ASPIRO: patient-own-cell neurons
It will tell us whether grafts stay safe at one year. The first 8 people had no comparison group, so gains cannot be told from a placebo effect.
In short
An uncontrolled Phase 1/2a trial of neurons grown from each patient's own cells reported safe grafts and large motor gains in eight people at 12 months, but nothing yet separates the cells from placebo effect.
- What it is
- Trial in people
- Outcome
- Result due Mar 2027
- When
- 2024–2026
- Size
- 15 people · Phase 2
- Approach
- Replace or repair what's lost
- Research lane
- Cell replacement
- Trial registry
- NCT06344026
- Last checked
- 19 Oct 2026
The research record
This is the project's file for this landmark, as written and checked. Sources are listed at the end; anything not yet confirmed is marked "Not yet verified".
Who
Aspen Neuroscience (product sasineprocel, formerly ANPD001), with investigator Chad Christine (quoted in the reports), funded in part by CIRM. Registered as NCT06344026.
What happened
In ASPIRO, each patient's skin fibroblasts are reprogrammed into induced stem cells and then into dopamine-neuron precursors, which are delivered to the putamen on both sides. The press reports give an age range of 50 to 70; the registry allows 40 to 75. The company says this avoids the chronic immunosuppression that donor cells need. Registry (checked 19 Oct 2026): Phase 1, open-label, single group, started 23 Jan 2024, enrolling by invitation, primary measure safety at 1 year, primary completion estimated 30 Mar 2027, 9 planned (more were dosed since; see below).
At the 2026 AD/PD conference (Copenhagen, 18 March 2026), 12-month data on the first eight patients (four lower dose, four higher) were presented. No serious surgical adverse events, no severe graft-induced dyskinesia, and no symptomatic bleeding or infarction. F-DOPA PET indicated survival of the grafts. Average improvements were: good "on" time +2.1 h (low dose) and +2.4 h (high dose); MDS-UPDRS Part III (motor exam, off medication) -15.5 and -13.5 points; quality of life (PDQ-39) -51.6% and -28.5%. At 6 months, the first three patients had a 45% mean improvement in the motor exam. Several patients reduced their levodopa dose. Dose per hemisphere was 5 million cells (low) and 5 to 10 million (high), according to CGTLive. The 6-month figure for the first three patients also included a 71% improvement in MDS-UPDRS Part II (daily living). By 30 June 2026 the company said 15 patients had been dosed in total; cohorts 3 and 4 use a frozen, thaw-and-inject formulation instead of the fresh product.
Why it moved us toward a cure
It extends the single-patient proof in landmark 73 to a series, offering a graft that might need no immunosuppression, unlike the trials in landmark 10 and 74.
Outcome
Pending: the registry's primary completion is March 2027 (its estimate), when the one-year safety data for all cohorts should be in. The 12-month data cover eight unblinded patients with no control group, so gains cannot be separated from placebo or from surgery effects; analysts note cost and competition from the Phase 3 bemdaneprocel. The company said in June 2026 it plans a Phase 3 later in 2026; no start has been found.
Sources
- NeurologyLive, 19 Mar 2026
- CGTLive on cohorts 3 and 4, 9 Jul 2026 (company release of 30 Jun 2026)
- ClinicalTrials.gov NCT06344026 (API checked 19 Oct 2026; last update 14 May 2026)
- Clinical Trials Arena analyst comment, 26 Mar 2026
- Not yet verified: Aspen's own press release and abstract (secondary reports only); peer-reviewed publication (NeurologyLive cites a 6-month report, Fraint et al., Parkinsonism Relat Disord 2025;134:107630, which I could not find in Europe PMC); Phase 3 start; the exact date of the 6-month release; why the registry still lists 9 planned (it was last updated 14 May 2026, and 15 were dosed by 30 Jun 2026).
How it connects
Built on
- builds on First graft of a patient's own iPSC neurons · 2020
Led to
None recorded.