PMID- 34717765
OWN - NLM
STAT- MEDLINE
DCOM- 20220323
LR  - 20220323
IS  - 1757-6512 (Electronic)
IS  - 1757-6512 (Linking)
VI  - 12
IP  - 1
DP  - 2021 Oct 30
TI  - Treatment of knee osteoarthritis with intra-articular injection of allogeneic 
      adipose-derived stem cells (ADSCs) ELIXCYTE(R): a phase I/II, randomized, 
      active-control, single-blind, multiple-center clinical trial.
PG  - 562
LID - 10.1186/s13287-021-02631-z [doi]
LID - 562
AB  - OBJECTIVE: To evaluate the safety and efficacy of intra-articular (IA) injection 
      of allogeneic adipose-derived stem cells (ADSCs) ELIXCYTE(R) for knee 
      osteoarthritis. METHODS: This was a patient-blind, randomized, active-control 
      trial consisted of 4 arms including hyaluronic acid (HA) control and 3 ELIXCYTE(R) 
      doses. A total of 64 subjects were screened, and 57 subjects were randomized. The 
      primary endpoints included the changes from baseline to post-treatment visit of 
      Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score 
      at Week 24 and the incidence of adverse events (AEs) and serious adverse events 
      (SAEs). RESULTS: No ELIXCYTE(R)-related serious adverse events were reported during 
      96 weeks of follow-up and no suspected unexpected serious adverse reaction 
      (SUSAR) or death was reported. The changes of the primary endpoint, WOMAC pain 
      score at Week 24, showed significant differences in all ELIXCYTE(R) groups, as well 
      as in HA groups between post-treatment visit and baseline. The ELIXCYTE(R) groups 
      revealed significant decreases at Week 4 compared to HA group in WOMAC total 
      scores, stiffness scores, functional limitation scores suggested the potential of 
      ELIXCYTE(R) in earlier onset compared to those from HA. The significant differences 
      of visual analog scale (VAS) pain score and Knee Society Clinical Rating System 
      (KSCRS) functional activities score at Week 48 after ELIXCYTE(R) administration 
      suggested the potential of ELIXCYTE(R) in the longer duration of the effectiveness 
      compared to HA group. CONCLUSIONS: ELIXCYTE(R) for knee osteoarthritis treatment 
      was effective, safe, and well-tolerated. The efficacy results were showed that 
      ELIXCYTE(R) conferred the earlier onset of reductions in pain scores and 
      improvements in functional scores than HA group. TRIAL REGISTRATION: 
      ClinicalTrials.gov Identifier: NCT02784964. Registered 16 May, 
      2016-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02784964.
CI  - (c) 2021. The Author(s).
FAU - Chen, Cheng-Fong
AU  - Chen CF
AD  - Division of Joint Reconstruction, Department of Orthopedics and Traumatology, 
      Taipei Veterans General Hospital, Taipei, Taiwan.
AD  - Department of Surgery, School of Medicine, National Yang Ming Chiao Tung 
      University, Taipei, Taiwan.
FAU - Hu, Chih-Chien
AU  - Hu CC
AD  - Division of Joint Reconstruction, Department of Orthopedic Surgery, Chang Gung 
      Memorial Hospital, Linkou, Taiwan.
AD  - Bone and Joint Research Center, Chang Gung Memorial Hospital, Linkou, Taiwan.
AD  - College of Medicine, Chang Gung University, Taoyuan, Taiwan.
FAU - Wu, Chen-Te
AU  - Wu CT
AD  - Department of Medical Imaging and Intervention, Chang Gung Memorial Hospital, 
      Linkou, Taiwan.
FAU - Wu, Hung-Ta H
AU  - Wu HH
AD  - Department of Radiology, Taipei Veterans General Hospital, Taipei, Taiwan.
AD  - Department of Radiology, School of Medicine, National Yang Ming Chiao Tung 
      University, Taipei, Taiwan.
FAU - Chang, Chun-Shin
AU  - Chang CS
AD  - Craniofacial Research Center, Department of Medical Research, Department of 
      Plastic and Reconstructive Surgery and Department of Craniofacial Orthodontics, 
      Chang Gung Memorial Hospital, Taoyuan, Taiwan.
AD  - Department of Chemical and Materials Engineering, College of Engineering, Chang 
      Gung University, Taoyuan, Taiwan.
FAU - Hung, Yi-Pei
AU  - Hung YP
AD  - UnicoCell BioMed Co. Ltd., Taipei, Taiwan.
FAU - Tsai, Chia-Chu
AU  - Tsai CC
AD  - UnicoCell BioMed Co. Ltd., Taipei, Taiwan.
FAU - Chang, Yuhan
AU  - Chang Y
AUID- ORCID: 0000-0002-7369-0300
AD  - Division of Joint Reconstruction, Department of Orthopedic Surgery, Chang Gung 
      Memorial Hospital, Linkou, Taiwan. yhchang@cgmh.org.tw.
AD  - Bone and Joint Research Center, Chang Gung Memorial Hospital, Linkou, Taiwan. 
      yhchang@cgmh.org.tw.
AD  - College of Medicine, Chang Gung University, Taoyuan, Taiwan. yhchang@cgmh.org.tw.
LA  - eng
SI  - ClinicalTrials.gov/NCT02784964
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20211030
PL  - England
TA  - Stem Cell Res Ther
JT  - Stem cell research & therapy
JID - 101527581
RN  - 9004-61-9 (Hyaluronic Acid)
SB  - IM
MH  - Double-Blind Method
MH  - *Hematopoietic Stem Cell Transplantation
MH  - Humans
MH  - Hyaluronic Acid/therapeutic use
MH  - Injections, Intra-Articular
MH  - *Osteoarthritis, Knee/drug therapy
MH  - Single-Blind Method
MH  - Treatment Outcome
PMC - PMC8557559
OTO - NOTNLM
OT  - ADSCs
OT  - Adipose tissue-derived stem cells
OT  - ELIXCYTE(R)
OT  - HA
OT  - Hyaluronic acid
OT  - KSCRS
OT  - Knee osteoarthritis
OT  - VAS
OT  - WOMAC
COIS- The authors declare that they have no competing interests.
EDAT- 2021/11/01 06:00
MHDA- 2022/03/24 06:00
PMCR- 2021/10/30
CRDT- 2021/10/31 20:40
PHST- 2021/08/01 00:00 [received]
PHST- 2021/10/04 00:00 [accepted]
PHST- 2021/10/31 20:40 [entrez]
PHST- 2021/11/01 06:00 [pubmed]
PHST- 2022/03/24 06:00 [medline]
PHST- 2021/10/30 00:00 [pmc-release]
AID - 10.1186/s13287-021-02631-z [pii]
AID - 2631 [pii]
AID - 10.1186/s13287-021-02631-z [doi]
PST - epublish
SO  - Stem Cell Res Ther. 2021 Oct 30;12(1):562. doi: 10.1186/s13287-021-02631-z.