Table 1 List of representative clinical trials using human fetal tissues.
Number of patients | Average age of cohort (range) | Disease duration (years) | Number of fVM/side (age) | Grafted site | Immuno-suppression (period) | Follow-up period | TH+ cell survival | Outcome | Adverse effect | Ref. |
---|---|---|---|---|---|---|---|---|---|---|
2 | 51.5 (48–55) | 7 | 3–4 (8–10 wks) | Unilateral (C+P) | CsA, AZA, PSL | 2 yrs | N/A | Minor improvement of motor speed for pronation-supination | None | |
2 | 55 (50–60) | 8–11 | 4 (6–7 wks) | Unilateral (P) | CsA, AZA, PSL (64 mo) | 10 yrs | n = 1 6246 (rostral); 10,728 (middle); 25,854 (caudal) | Improved rigidity and bradykinesia | None | |
7 | 56.3 (39–66) | 7–20 | 1 (7–8 wks) | 2 pts-unilateral(C+P); 5 pts-bilateral (P) | CsA, PSL in 4 pts | 1–4 yrs | N/A | Motor improvement; Shorter and less severe dyskinesia | None | |
2 | 36.5 (30–43) | 6 | 3–4 (6–8 wks) | Bilateral (C+P) | CsA (12 mo), AZA (18 mo), PSL (N/A) | 2 yrs | N/A | Improved motor functions | None | |
4 | 52 (47–63) | 10–21 | 1 (7–11 wks) | Unilateral (C) | CsA (6 mo) | 1.5 yrs | N/A | Improved motor functions (3/4) | Transient panic disorder (1/4) | |
2 | 56 (49–63) | 10–17 | 2–3 (6–9 wks) | 1 pt–unilateral (P); 1 pt–bilateral (C+P) | CsA (7 mo), AZA, PSL | 1.5 yrs | N/A | Improved motor functions | Transient obsessive compulsive disorder (1/2) | |
4 | 52.3 (39–61) | 8–22 | 3–4 (6.5–9 wks) | Bilateral (P) | CsA (6 mo) | 1.5 yrs | Patient 1 (18 mo): 128,162 (right), 81,905 (left); Patient 2 (19 mo): 79,207 (right), 39,151 (left) | Improved motor functions; Resolution of dyskinesias | Cortical hemorrhage (1/4); Transient confusion and hallucinations (1/4) | |
5 | 57.4 (48–67) | 13–22 | 1–3 (6–9 wks) | 1 pt–unilateral (P); 4 pts–unilateral (C+P) | CsA (7 mo), AZA, PSL | 3 yrs | N/A | Modest improvement in daily living activities (1/5) | None | |
6 | 48.8 (43–58) | 7–16 | 4–8 (6–8 wks) | 4 pts-unilateral (P); 1 pt-unilateral (C+P) | CsA, AZA, PSL | \({{{{{\rm{\le }}}}}}\)18 yrs | N/A | Major improvement (4/6); Modest changes (2/6) | Atypical parkinsonism (1/6); Dementia (1/6) | |
20 | \(\le\) 60 yrs: 50 ± 8; > 60 yrs: 65 ± 4 | \(\le\) 60: 13 ± 3; > 60: 15 ± 6 | 2 (7–8 wks) | Bilateral (P) | None | 3 yrs | Patient 1 (7 mo): 24,115 (right), 38,392 (left); Patient 2 (36 mo): 36,796 (right), 6840 (left) | Improved UPDRS score in younger pts(\(\le\) 60 yrs), but not in older pts(> 60 yrs) | Dystonia and dyskinesia (5/20) | |
3 | 53 (48–59) | 10–14 | 6 (6–9 wks) | Bilateral (P+SN) | CsA (6 mo) | 1.1 yrs | N/A | Improved UPDRS score; Decreased L-DOPA dose requirement (1/3) | None | |
23 | 58.5 (30–75) | 11 | 1–4 (6–9 wks) | Bilateral (P) | CsA (6 mo) | 2 yrs | 1 fVM (n = 2): 30k/side; 4 fVM (n = 2): 70k-120k/side | No improvement | Dyskinesia (13/23) | |
2 | 64 (59–69) | 11–15 | 2–3 (6–9 wks) | Bilateral (P) | CsA (6 mo) | 3 yrs | Patient 1 (44 mo): 127,189 (right), 98,913 (left); Patient 2 (52 mo): 202,933 (right), 4289 (left) | Improved UPDRS and Dyskinesia scores | None |