Table 1 List of representative clinical trials using human fetal tissues.

From: Past, present, and future of cell replacement therapy for parkinson’s disease: a novel emphasis on host immune responses

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

14,24

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

25,26

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

18

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

31

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)

29

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)

17

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)

19,22,23

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

15

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)

20,21,30

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)

37

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

16

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)

38

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

27

  1. fVM fetal ventral mesencephalic, yrs years, wks weeks, mo months, C Caudate, P Putamen, SN Substantia Nigra, CsA cyclosporin A, AZA Azathioprine, PSL Prednisolone, pts patients, N/A not available, UPDRS Unified Parkinson’s Disease Rating Scale, Ref. Reference.