Table 1.

Clinical Trial of Umbilical Cord Mesenchymal Stem Cells Therapy of RA from ClinicalTrials.gov

NCT Number	Interventions	Outcome Measures	Age	Phases	Enrollment	Study Designs
NCT02643823	hUC-MSC+DMARDs; DMARDs	SAE; RA Serology; DAS 28 Index	18–80	Phase 1	40	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
NCT01985464	hUC-MSC	AE;28-DAS; EULAR; QOL; HAQ; at months 3 and 12 of CRP; ESR anti-CAM; RF; EULAR	≥18	Phase 1|Phase 2	20	Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
NCT01547091	UC-MSCs; DMARDs; UCMSC+DMARDs	Safety of MSC treatment; RA Serology; DAS 28 Index; Patient’s assessment of pain.	18–70	Phase 1|Phase 2	200	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
NCT03828344	hUC-MSC; Placebo	Frequency of AE; SAE All following indexes at Week 12 and Week 24:ACR20; ACR50; ACR70; DAS28-CRP; HAQ-DI score; SDAI; RF; anti-CCP	18–70	Phase 1	16	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
NCT03798028	UC-MSCs	BT; HGB; FVC; DLCO; ACR 20; ACR 50; ACR 70; WBC; PC; FVC DLCO; Lung CT; 6MWT	18–70	Not Applicable	250	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment
NCT03618784	FURESTEM-RA Inj; Sterile saline	AE; ACR20,50,70; EULAR; DAS28-ESR; KHAQ; CDAI; 100mm Pain VAS; consumed amount of rescue medicine; Change in Cytokine (TNF-a, IL-1b, IL-4, IL-6, IL-8, IL-10, IL-13, IL-17A, IL-21, IL-22)	19–80	Phase 1|Phase 2	33	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Notes: Placebo, same suspension as BX-U001 but without cells. NCT Number was identified by ClinicalTrials.gov Identifier in Medline.

Abbreviations: UC-MSCs, umbilical cord derived mesenchymal stem cells; DAS 28, Disease Activity Score 28 joint; AE, adverse events; ESR, erythrocyte sedimentation rate; RF rheumatoid factor; DMARDs, drug rheumatoid arthritis with disease-modifying drugs; SAE, serious adverse events; DAS28-CRP, disease activity score 28-joint count using C reactive protein; HAQ-DI, health assessment questionnaire disability index; SDAI, Simplified Disease Activity Index; anti-CCP, anti-cyclic citrullinated peptide; HGB, hemoglobin; FVC, forced vital capacity; ACR, American College of Rheumatology; EULAR, European League Against Rheumatism; KHAQ, Korean Health Assessment Questionnaire; CDAI, clinical disease activity index; VAS, visual analogue scale; QOL, quality of life measure; CRC, reactive protein; anti-CAM, anti-citrulline antibody measure; BT, blood routine; DLCO, diffusing lung capacity for carbon monoxide; 6MWT, six-minute walk test; WBC, white blood cell count; PC, platelet count; IL, interleukin; FURESTEM-RA Inj, the allogeneic umbilical cord blood-derived mesenchymal stem cells.