Thymosin-α1 for Recurrent Implantation Failure

Summary

Clinical trial evaluating the safety and efficacy of Thymosin-α1 (Tα1) as an adjunctive immunomodulatory therapy in women with unexplained recurrent implantation failure (RIF) undergoing IVF/ICSI cycles.

Timeline

Start

2026-02-11

Primary completion

2027-02

Completion

2027-06

Publications

• Background Graham JJ, Longhi MS, Heneghan MA. T helper cell immunity in pregnancy and influence on autoimmune disease progression. J Autoimmun. 2021 Jul;121:102651. doi: 10.1016/j.jaut.2021.102651. Epub 2021 May 18.
• Background Dominari A, Hathaway Iii D, Pandav K, Matos W, Biswas S, Reddy G, Thevuthasan S, Khan MA, Mathew A, Makkar SS, Zaidi M, Fahem MMM, Beas R, Castaneda V, Paul T, Halpern J, Baralt D. Thymosin alpha 1: A comprehensive review of the literature. World J Virol. 2020 Dec 15;9(5):67-78. doi: 10.5501/wjv.v9.i5.67.
• Background Kaufmann RA, Welch RA, Mutchnick MG. Low periconceptional maternal serum thymosin alpha 1 levels are associated with blighted pregnancies. Am J Reprod Immunol. 1993 Apr;29(3):171-5. doi: 10.1111/j.1600-0897.1993.tb00583.x.
• Background Robertson SA. Immune tolerance in pregnancy. Nat Rev Immunol. 2020;20:67-82
• Background Garaci E, Favalli C, Pica F, Sinibaldi Vallebona P, Palamara AT, Matteucci C, Pierimarchi P, Serafino A, Mastino A, Bistoni F, Romani L, Rasi G. Thymosin alpha 1: from bench to bedside. Ann N Y Acad Sci. 2007 Sep;1112:225-34. doi: 10.1196/annals.1415.044. Epub 2007 Jun 28.
• Background Lin, Y. et al. Maternal serum thymosin α1 and β4 levels in early pregnancy and risk of miscarriage. [Chinese study showing lower Tα1 in miscarriage]
• Background Romani L, et al. Thymosin alpha-1: a safe and effective immune modulator in clinical practice. Expert Opin Biol Ther. 2016;16(5):691-707.
• Background Goldstein AL, et al. Biological activities of thymosin alpha 1: clinical applications in disease modulation. Int Immunopharmacol. 2004;4(13):1781-1789.
• Background Li J, et al. Case report: successful pregnancy following thymosin-α1 therapy in recurrent implantation failure. Pharm J. 2018.
• Background Garofalo C, et al. Serum thymosin alpha-1 levels in early pregnancy and risk of miscarriage. Hum Reprod. 1992;7(9):1336-1339.

Drugs

Indications