Safety and Tolerability of a Single Intravenous Infusion of BX-U001 in Refractory Rheumatoid Arthritis

Sponsor
Baylx Inc.
Study ID
NCT03828344
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • hUC-MSC suspension — BIOLOGICAL
    Patients will be treated at dose of 0.75×10\^6 cells/kg of body weight (Cohort 1) or 1.5×10\^6 cells/kg of body weight (Cohort 2) via a single IV infusion using a blood transfusion kit.
  • Placebo — BIOLOGICAL
    Placebo contains the same cell suspension as BX-U001 but without cells.

Study Details

This is a phase 1, randomized, placebo-controlled, double-blind, single-dose, clinical trial examining the safety and biological effects of allogeneic fresh human umbilical cord tissue-derived mesenchymal stem cell product BX-U001, given by intravenous (IV) infusion, to rheumatoid arthritis (RA) patients with moderate to severe disease activity, who are not well controlled by their current treatments. Two doses of BX-U001 will be tested in 16 patients. The subjects will receive a one-time IV infusion of BX-U001 and monitored for 52 weeks.

Key Dates

First listed
Feb 4, 2019
Start date
Dec 1, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Feb 20, 2028

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: hUC-MSC treatment
    BX-U001 (hUC-MSC suspension) will be tested at dose of 0.75 or 1.5×10\^6 cells/kg of body weight via a single IV infusion using a blood transfusion kit.
  • Placebo Comparator: Placebo control
    The control arm will be given placebo which contains the same cell suspension solution but without cells. Placebo will be given the same way as BX-U001 via a single IV infusion using a blood transfusion kit.

Primary Outcome Measure

Frequency of Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: 12 months after infusion ]

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