PMID- 28713639
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 2155-1790 (Print)
IS  - 2155-1790 (Electronic)
IS  - 2155-1790 (Linking)
VI  - 9
IP  - 3
DP  - 2017
TI  - A Prospective, Nonrandomized, no Placebo-Controlled, Phase I/II Clinical Trial 
      Assessing the Safety and Efficacy of Intramuscular Injection of Autologous 
      Adipose Tissue-Derived Mesenchymal Stem Cells in Patients With Severe Buerger's 
      Disease.
PG  - 87-102
LID - 10.3727/215517916X693069 [doi]
AB  - Buerger's disease is a rare and severe disease affecting the blood vessels of the 
      limbs. Adipose tissue-derived mesenchymal stem cells (ADSCs) have the potential 
      to cure Buerger's disease when developed as a stem cell drug. In the present 
      study, we conducted a prospective, nonrandomized, no placebo-controlled, phase 
      I/II clinical trial with a 2-year follow-up questionnaire survey. A total of 17 
      patients were intramuscularly administered autologous ADSCs at a dose of 5 
      million cells/kg. The incidence of adverse events (AEs), adverse drug reaction 
      (ADR), and serious adverse events (SAEs) was monitored. No ADRs and SAEs related 
      to stem cell treatment occurred during the 6-month follow-up. In terms of 
      efficacy, the primary endpoint was increase in total walking distance (TWD). The 
      secondary endpoint was improvement in rest pain, increase in pain-free walking 
      distance (PFWD), toe-brachial pressure index (TBPI), transcutaneous oxygen 
      pressure (TcPO(2)), and arterial brachial pressure index (ABPI). ADSCs 
      demonstrated significant functional improvement results including increased TWD, 
      PFWD, and rest pain reduction. No amputations were reported during the 6-month 
      clinical trial period and in the follow-up questionnaire survey more than 2 years 
      after the ADSC injection. In conclusion, intramuscular injection of ADSCs is very 
      safe and is shown to prompt functional improvement in patients with severe 
      Buerger's disease at a dosage of 300 million cells per 60 kg of body weight. 
      However, the confirmatory therapeutic efficacy and angiogenesis need further 
      study.
FAU - Ra, Jeong Chan
AU  - Ra JC
AD  - Biostar Stem Cell Research Institute, R Bio Co. Ltd., Seoul, Republic of Korea.
FAU - Jeong, Euicheol C
AU  - Jeong EC
AD  - daggerDepartment of Plastic Surgery, SMG-SNU Boramae Medical Center, Seoul, Republic 
      of Korea.
AD  - double daggerDepartment of Plastic and Reconstructive Surgery, College of Medicine, Seoul 
      National University, Seoul, Republic of Korea.
FAU - Kang, Sung Keun
AU  - Kang SK
AD  - Biostar Stem Cell Research Institute, R Bio Co. Ltd., Seoul, Republic of Korea.
FAU - Lee, Seog Ju
AU  - Lee SJ
AD  - Biostar Stem Cell Research Institute, R Bio Co. Ltd., Seoul, Republic of Korea.
FAU - Choi, Kyoung Ho
AU  - Choi KH
AD  - Biostar Stem Cell Research Institute, R Bio Co. Ltd., Seoul, Republic of Korea.
LA  - eng
PT  - Journal Article
DEP - 20161003
PL  - United States
TA  - Cell Med
JT  - Cell medicine
JID - 101544564
PMC - PMC5509019
OTO - NOTNLM
OT  - Adipose tissue
OT  - Autologous
OT  - Buerger's disease
OT  - Mesenchymal stem cells (MSCs)
COIS- E.C. Jeong declares no conflict of interest.
EDAT- 2017/07/18 06:00
MHDA- 2017/07/18 06:01
PMCR- 2016/10/03
CRDT- 2017/07/18 06:00
PHST- 2017/07/18 06:00 [entrez]
PHST- 2017/07/18 06:00 [pubmed]
PHST- 2017/07/18 06:01 [medline]
PHST- 2016/10/03 00:00 [pmc-release]
AID - CM109 [pii]
AID - 10.3727/215517916X693069 [doi]
PST - epublish
SO  - Cell Med. 2016 Oct 3;9(3):87-102. doi: 10.3727/215517916X693069. eCollection 
      2017.