PMID- 35241141
OWN - NLM
STAT- MEDLINE
DCOM- 20220324
LR  - 20220531
IS  - 1757-6512 (Electronic)
IS  - 1757-6512 (Linking)
VI  - 13
IP  - 1
DP  - 2022 Mar 3
TI  - Safety and efficacy of autologous, adipose-derived mesenchymal stem cells in 
      patients with rheumatoid arthritis: a phase I/IIa, open-label, non-randomized 
      pilot trial.
PG  - 88
LID - 10.1186/s13287-022-02763-w [doi]
LID - 88
AB  - OBJECTIVE: The present study is a phase I/IIa non-randomized, open-label study to 
      evaluate safety and efficacy of a single, intravenous infusion of autologous, 
      adipose-derived mesenchymal stem cells (adMSCs) over a period of 52 weeks, in 
      patients with active rheumatoid arthritis (RA). METHODS: 15 eligible RA patients 
      aged 18-65 years were enrolled and followed up at weeks 4, 12, 26 and 52 after 
      receiving a single intravenous dose of 2 x 10(8) adMSCs. Efficacy was examined 
      using American College of Rheumatology (ACR66/68 score) criteria for swollen and 
      tender joint counts (S/TJC), and serum TNF-alpha, IL-6, CRP, and ESR levels. Safety 
      endpoints included measures of hematologic, hepatic, and renal function. RESULTS: 
      ACR66/68 scores for both S/TJC showed significant improvements with large effect 
      sizes (ES) at week 52 vs baseline (p < 0.01, ES = 0.83 and p < 0.001, ES = 0.93 
      respectively). Medium to large ES were also obvious for ACR66/68 scores measured 
      at other timepoints. Levels of inflammatory markers, TNF-alpha, IL-6 and ESR remained 
      unchanged compared to baseline. However, a difference in CRP levels with a small 
      effect size was observed at week 4 (p = 0.229, ES = 0.33) with further 
      improvement at week 52 (p = 0.183, ES = 0.37). Post-intervention, levels of 
      hematologic, hepatic, and renal function remained largely unchanged (p > 0.05). 
      No acute or long-term serious adverse events (AEs) occurred. CONCLUSIONS: The 
      results indicated that a single, intravenous administration of autologous adMSCs 
      is safe and efficacious for improvement in joint function in patients with active 
      RA. Data from the current study supports the exploration of ad-MSCs as a 
      therapeutic intervention for RA. Trial Registration Clinical trial registration 
      number: NCT03691909. Registered September 27, 2018- Retrospectively registered ( 
      https://clinicaltrials.gov/show/NCT03691909 ).
CI  - (c) 2022. The Author(s).
FAU - Vij, Ridhima
AU  - Vij R
AUID- ORCID: 0000-0003-3130-5133
AD  - Hope Biosciences Stem Cell Research Foundation, 16700 Creek bend Dr., Sugar Land, 
      TX, 77478, USA. ridhima@hopebio.org.
FAU - Stebbings, Kevin A
AU  - Stebbings KA
AUID- ORCID: 0000-0002-9130-0812
AD  - Hope Biosciences Stem Cell Research Foundation, 16700 Creek bend Dr., Sugar Land, 
      TX, 77478, USA.
FAU - Kim, Hosu
AU  - Kim H
AD  - Hope Biosciences, Sugar Land, TX, USA.
FAU - Park, Hyeonggeun
AU  - Park H
AD  - Hope Biosciences, Sugar Land, TX, USA.
FAU - Chang, Donna
AU  - Chang D
AD  - Hope Biosciences, Sugar Land, TX, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03691909
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220303
PL  - England
TA  - Stem Cell Res Ther
JT  - Stem cell research & therapy
JID - 101527581
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Tumor Necrosis Factor-alpha)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - *Antirheumatic Agents/adverse effects
MH  - *Arthritis, Rheumatoid/drug therapy
MH  - Double-Blind Method
MH  - Humans
MH  - *Mesenchymal Stem Cells
MH  - Middle Aged
MH  - Treatment Outcome
MH  - Tumor Necrosis Factor-alpha
MH  - Young Adult
PMC - PMC8896321
OTO - NOTNLM
OT  - Adipose-derived mesenchymal stem cell
OT  - Autologous
OT  - Clinical trial
OT  - Efficacy
OT  - Intravenous
OT  - Rheumatoid arthritis
COIS- Ridhima Vij and Kevin Stebbings were the employees of Hope Biosciences Stem Cell 
      Research Foundation, and declare that they have no competing interests that could 
      have appeared to influence the work reported in this paper. Hosu Kim, Hyeonggeun 
      Park and Donna Chang declare the following financial interests which may be 
      considered as potential competing interests. The above listed authors are 
      employees of Hope Biosciences LLC.
EDAT- 2022/03/05 06:00
MHDA- 2022/03/25 06:00
PMCR- 2022/03/03
CRDT- 2022/03/04 05:33
PHST- 2021/11/22 00:00 [received]
PHST- 2022/02/08 00:00 [accepted]
PHST- 2022/03/04 05:33 [entrez]
PHST- 2022/03/05 06:00 [pubmed]
PHST- 2022/03/25 06:00 [medline]
PHST- 2022/03/03 00:00 [pmc-release]
AID - 10.1186/s13287-022-02763-w [pii]
AID - 2763 [pii]
AID - 10.1186/s13287-022-02763-w [doi]
PST - epublish
SO  - Stem Cell Res Ther. 2022 Mar 3;13(1):88. doi: 10.1186/s13287-022-02763-w.