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Open-label RCT · PMID 41887933

Thymosin alpha1 improves the outcomes of patients with HBV-related ACLF by restoring immune balance — VialBase Research

Ta1 + SMT significantly increased 90-day transplant-free survival vs SMT alone

Last updated · 2026 · Li ZH, Wu LL, Zhu YQ, et al. · Immunopharmacol Immunotoxicol
Key findings
  • Ta1 + SMT significantly increased 90-day transplant-free survival vs SMT alone
  • Ta1 reduced Treg frequencies and CD226low/- Treg subsets at weeks 4-8
  • Survivors had higher effector T-cell proportions and pro-inflammatory cytokines at baseline
  • Ta1 moderated late-stage hyperinflammation without compromising early immune activation

Ta1 Restores Immune Balance in HBV-ACLF (PMID: 41887933)

Study Design

  • Open-label RCT (NCT03082885)
  • 73 patients with HBV-related acute-on-chronic liver failure
  • SMT alone (n=38) vs SMT + Ta1 (n=35)
  • Flow cytometry for immune subsets, ELISA for cytokines

Key Results

  • Primary: Ta1 significantly increased 90-day transplant-free survival
  • Survivors had higher baseline TE cells and lower Tregs vs non-survivors
  • Survivors had higher initial IL-6, TNF-alpha, IFN-gamma
  • Ta1 reduced CD226low/- Treg subsets at weeks 4-8
  • Ta1 moderated late-stage hyperinflammatory response

Mechanism Insight

Ta1 breaks the cycle of hyperinflammation and immunosuppression in ACLF by rebalancing T-cell differentiation (reducing Tregs, maintaining effectors) and modulating cytokine production.

Relevance

Strong human evidence for Ta1 in liver failure. Demonstrates the dual action: anti-inflammatory when needed, pro-immune when needed. Supports Thymosin-Alpha-1 as an immune balancer rather than simple stimulant.

See Also

View on PubMed · PMID 41887933 →