Skip to main content

Table 1 Clinical trials of MSC transplantation for ESLD

From: Enhancing mesenchymal stem cell survival and homing capability to improve cell engraftment efficacy for liver diseases

Liver disease

Cell type

N

Injected site

Phase

Cell dose

Follow-up

Out come

References

DLC

UC-MSC

36

PVI

I/II

0.5–1 × 106/kg/3 times, allogeneic

10 years

3–5 years survival rate was significantly improved

[17]

HBV-DLC

UC-MSC

108

PVI

I/II

0.5 × 106/kg/3 times, allogeneic

75 months

ALT, Tbil, CHE, and MELD scores were significantly improved; long-term survival was significantly improved

[18]

HBV-ACLF

BM-MSC

56

PVI

I

1.0–10 × 105/kg/4 times, allogeneic

24 weeks

Tbil and MELD scores were markedly improved; the incidence of severe infection was decreased

[19]

LC

BM-MSC

25

PVI

I

1 × 106/kg/1 time, autologous

6 months

MELD scores and ALB were improved; unmeasured HCV RNA level; hepatitis activity index scores were decreased

[21]

DLC

BM-MSC

15

PVI

I

1.2–2.95 × 108/people/1 time, autologous

1 year

No significant improvement

[20]

LC

BM-MSC

4

PVI

I

31.73 × 106/kg, autologous

1 year

MELD scores were improved; no side-effects

[97]

LC

BM-MSC

12

PVI

I/II

5.20 ± 0.63 × 109/people, autologous

2 years

Child–Pugh scores were significantly improved; α-Fetoprotein and PCNA were significantly elevated

[98]

HCV-LC

BM-MSC

20

ISI

I

1 × 107/people/1 time, autologous

6 months

Tbil, AST, ALT, PT, and INR levels were decreased; ALB and PC were significantly increased

[99]

Alcoholic-LC

BM-MSC

12

IAI

II

5 × 107/people/1 time, autologous

1 year

Child–Pugh scores were improved; TGF-β1, type 1 collagen, and α-SMA were significantly decreased

[100]

PBC

UC-MSC

5

PVI

I

0.5 × 106/kg/3 times, autologous

1 year

Serum alkaline phosphatase and γ-glutamyltransferase levels were increased; no obvious side-effects

[101]

HBV-LC

UC-MSC

30

PVI

I/II

0.5 × 106/kg/3 times, autologous

1 year

The ascites were significantly reduced; ALB was increased; Tbil and MELD scores were decreased

[102]

PBC

UC-MSC

10

PVI

I

3–5 × 105/kg/1 time, allogeneic

1 year

ALT, AST, g-GT, IgM, and CD8+ T cells were reduced; CD4+ CD25+ Foxp3+ T cells and IL-10 were increased

[103]

HCV-LC

BM-MSC

15

PVI

II

106/kg/1 time, autologous

6 months

Prothrombin concentration and ALB were increased; Tbil and MELD scores were decreased

[104]

DLC

BM-MSC

8

PVI n = 2

PI n = 6

I/II

3.0–5.0 × 107/people/1 time, autologous

24 weeks

MELD scores, prothrombin complex, serum creatinine, ALB, and Tbil were decreased

[105]

LC

BM-MSC

10

PVI

I

5.20 ± 0.639 × 109/people/1 time, autologous

4 months

ALB, total protein, Child–Pugh scores, Alpha-fetoprotein, and PCNA were improved

[106]

HCV-HCC

BM-MSC

20

PVI

I/II

1 × 106/kg/1 time, autologous

1 year

ALB, Tbil, INR, PC, and ALT were significantly improved

[107]

DLC

UC-MSC

50

IAI

I

3 × 107/people/1 time, autologous

24 weeks

ALB and pre-ALB were significantly increased; in the first 2–3 weeks, abdominal distension, oliguria, and edema were decreased

[108]

Alcoholic-LC

BM-MSC

37

IAI

II

5 × 107/people/1–2 time, autologous

12 months

The proportion of collagen was decreased; Child–Pugh scores were significantly improved; no side effects

[109]

LC

BM-MSC

1

IAI

I

1.2 × 108/people/2 times, autologous

12 months

Tbil was decreased; ALB was improved; the ascites was reduced

[110]

HBV-DLC

UC-MSC

50

PVI

I/II

4.0–4.5 × 108/people/2 times, allogeneic

52 weeks

Liver function level including ALB, Tbil, and prothrombin were improved during 3–5 weeks; IL-6 and TNF-α were decreased; TGF-β1 and IL-10 were significantly increased

[111]

LC

ADSC

7

IAI

I/II

3.3 × 105/kg/1 time, autologous

24 weeks

ALB and prothrombin activity were improved; no side effects

[112]

LC

ADSC

2

IAI

I

3.3/6.6 × 105/kg/1 time, autologous

1 year

HGF and IL-6 were increased after MSC infusion; ALB were maintained or improved

[113]

LF

BM-MSC

53

IAI

I/II

0.5–1 × 106/kg /1 time, autologous

192 weeks

ALB was increased after 2-week transplantation; the life quality was significantly improved

[114]

HCV-LF

BM-MSC

20

PVI

ISI

I

2 × 107/people/1 time, autologous

6 months

Child–Pugh scores, MELD scores, fatigue scale, and performance status were all improved; ascites, lower limb edema, and ALB level were improved

[115]

LT

BM-MSC

10

CI

I/II

1.5–3 × 106/kg/1 time, allogeneic

12 months

No significant improvement

[116]

HBV-ACLF

UC-MSC

11

IAI

I

1 × 108/people/1 time, allogeneic

24 months

Liver function levels including ALB, ALT, AST, Tbil, PT, INR, and MELD scores were all improved; the survival rate was significantly improved

[117]

ACLF

UC-MSC

24

PVI

I/II

0.5 × 106/kg/3 times, autologous

72 weeks

MELD scores, Tbil, and ALT were significantly decreased; ALB, cholinesterase, prothrombin activity, and platelet counts were all increased

[118]

  1. ACLF, acute-on-chronic liver failure; ADSC, adipose-derived MSC; ALB, albumin; ALT, alanine aminotransferase; α-SMA, α-smooth muscle actin; AST, aspartate transaminase; BM-MSC, bone marrow-derived MSC; CHE, cholinesterase; CI, central intravenous; DLC, decompensated liver cirrhosis; HBV, hepatic B virus; HCC, hepatocellular carcinoma; HCV, hepatic C virus; IAI, intrahepatic arterial injection; IL, interleukin; INR, international normalized ratio; ISI, intrasplenic injection; LC, liver cirrhosis; LF, liver failure; LT, liver transplantation; MELD, model for end-stage liver disease; PBC, primary biliary cirrhosis; PC, prothrombin concentration; PCNA, proliferating cell nuclear antigen; PI, portal injection; PVI, peripheral vein injection; PT, prothrombin time; Tbil, total bilirubin; TGF-β1, transforming growth factor-β1; TNF-α, tumor necrosis factor α; UC-MSC, umbilical cord-derived MSC