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Table 1 Clinical trials using BMMNCs and PBMNCs for CLI patients

From: Therapeutic strategies for cell-based neovascularization in critical limb ischemia

Author

Year

Cell type

Target disease

Delivery

Study population

Outcome

Follow-up

References

Esato et al.

2002

BMMNC

CLI

IM

8

↑Symptom, ↑thermography, complete ulcer healing; 2/3 (67%) major amputation rates; 0

Not determined

[20]

Tateishi-Yuyama et al.

2002

BMMNC and PBMNC

CLI

IM

45

↑Symptom, ↑ABI, ↑TcPO2, complete ulcer healing; 6/10 (60%) major amputation rates; not shown

4 and 24 weeks

[25]

Huang et al.

2005

PBMNC

CLI

IM

28

↑Symptom, ↑ABI, ↑LDP, complete ulcer healing; 14/18 (78%) major amputation rates; 0

3 months

[88]

Lenk et al.

2005

PBMNC

CLI

IA

7

↑Symptom, ↑ABI, ↑TcPO2, complete ulcer healing; not shown major amputation rates; 0

20 weeks

[89]

Miyamoto et al.

2006

BMMNC

CLI

IM

8

↑Symptom, no ∆ ABI, complete ulcer healing; 7/8 (88%) major amputation rates; 0

684 days

[81]

Durdu et al.

2006

BMMNC

CLI

IM

28

↑Symptom, ↑ABI, ↑LDP, complete ulcer healing; 15/18 (83%) major amputation rates; 0

16.6 months

[79]

Arai et al.

2006

BMMNC

CLI

IM

39

↑Symptom, ↑ABI, ↑TcPO2, complete ulcer healing; 3/8 (38%) major amputation rates; not shown

1 months

[90]

Kawamoto et al.

2009

PBMNC (CD34+)

CLI

IM

17

↑Symptom, ↑TBI, ↑TcPO2, no ∆ ABI, complete ulcer healing; not shown major amputation rates; 0

3 months

[91]

Prochazka et al.

2010

BMC

CLI

IM

96

↑Symptom, ↑ABI, ↑LDP, ↑SPP, no ∆ TcPO2, complete ulcer healing; 33/42 (79%) major amputation rates; 9/42 (21%)

4 months

[92]

Murphy et al.

2011

BMMNC

CLI

IM

29

↑Symptom, ↑FTP, ↑TBI, complete ulcer healing; 3/9 (33%) major amputation rates; 4/29 (14%)

12 months

[93]

Walter et al.

2011

BMMNC

CLI

IA

40

↑Symptom, no ∆ ABI, no ∆ TcPO2, complete ulcer healing; 3/15 (20%) major amputation rates; 3/19 (16%)

3 months

[78]

Losordo et al.

2012

PBMNC (CD34+)

CLI

IM

28

No ∆ symptom, no ∆ ABI, no ∆ TBI, complete ulcer healing; 2/5 (40%) major amputation rates; 5/16 (31%)

12 months

[94]

Tanaka et al.

2014

PBMNC (CD34+)

CLI

IM

5

↑Symptom, ↑SPP, ↑TcPO2, no ∆ ABI, complete ulcer healing; 2/5 (40%) major amputation rates; 0

5 months

[95]

Teraa et al.

2015

BMMNC

CLI

IA

160

↑Symptom, ↑ABI, ↑TcPO2, complete ulcer healing; 19/51 (37%) major amputation rates; 21/81 (26%)

9 months

[96]

  1. BMMNC bone marrow derived mononuclear cell, PBMNC peripheral blood mononuclear cell, BMC bone marrow cell, CLI critical limb ischemia, IM intramuscular, IA intraarterial, ↑ improved, ∆ change, ABI ankle brachial pressure index, TcPO 2 transcutaneous oxygen pressure, SPP skin perfusion pressure, LDP laser Doppler perfusion, TBI toe brachial pressure index, FTP first toe pressure