Landmark 318 · Trial in people
Olanow: sham-controlled fetal grafts
In 34 people, grafts did not clearly beat a placebo operation at 24 months. 56% of grafted people had unwanted movements that continued off medication.
In short
In 34 people with advanced Parkinson's, fetal grafts did not significantly beat a placebo operation at 24 months, and 56% of grafted patients had dyskinesias that continued off medication.
- What it is
- Trial in people
- Outcome
- Did not work
- When
- 2003
- Size
- 34 people · Phase 2
- Approach
- Replace or repair what's lost
- Research lane
- Cell replacement
- 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
C. Warren Olanow, Christopher Goetz, Jeffrey Kordower, A. Jon Stoessl, Thomas Freeman and colleagues. Annals of Neurology 2003;54:403–414.
What happened
- 34 patients with advanced Parkinson's joined a 24-month double-blind, placebo-controlled trial. They were randomised to a graft on both sides using one donor per side, four donors per side, or a placebo procedure. A press-reported split was 23 treated and 11 on placebo.
- Main measure: change in the off-medication motor UPDRS score between baseline and the final visit.
- No significant overall effect (P = 0.244). Placebo patients worsened by 9.4 points, the one-donor group by 3.5, and the four-donor group improved by 0.72. Four donors versus placebo gave P = 0.096.
- In milder patients, stratified by baseline severity, there was a treatment effect (P = 0.006).
- Fluorodopa uptake rose in both graft groups, and post-mortem study showed strong survival of dopamine neurons.
- 56% of transplanted patients developed dyskinesias that persisted after an overnight stop of medication.
- The authors wrote that fetal nigral transplantation cannot be recommended as a therapy on these results.
Why it moved us toward a cure
It confirmed the first sham-controlled result (landmark 317): grafts survive and make dopamine, but a clinical gain was not shown in the whole group. The high rate of dyskinesias while off medication drove the search for purer cell sources (landmark 215). It also suggested milder patients might benefit more, a lesson passed to modern designs (landmark 10). Parent trial family: landmark 3.
Outcome
Dead end for fetal tissue as a routine therapy. The open-label European follow-up is landmark 319.
Sources
- Olanow et al., Ann Neurol 2003;54:403–414, DOI 10.1002/ana.10720 (abstract via Europe PMC, PMID 12953276)
- Swift and Huxtable, Bioethics 2013 (PMC3654166): confirms 34 recruited, 11 on placebo, 56% dyskinesias.
- Not yet verified: the authors' institutions; enrolment dates and sites; the full text; the sub-group sizes.
How it connects
Built on
- tests First fetal dopamine-cell transplants · 1987
- builds on Freed: sham-controlled fetal grafts · 2001
Led to
None recorded.