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Thymosin Alpha 1 in Recurrent Implantation Failure : Dr Sharda Jain

Thymosin Alpha 1 in Recurrent Implantation Failure :

1 of 67
Thymosin Alpha 1
in
Recurrent
Implantation
Failure
Dr. Sharda Jain
Lifecare IVF Center
Gagan Vihar,, New Delhi, 110051
When it comes to having a child, many
people will exhaust any and all
avenues – financial or geographic – to
find a way around.
Wide Variability In The Definition Of RIF
To date there is a lack of a clear-cut consensus on the
definition of RIF
 Three generic definitions are considered according to:
1. Number of unsuccessful assisted reproduction treatment cycles
2. Number of embryos transferred
3. A combination of both factors
Ref:1. Laufer N, Simon A (2012) Fertil Steril 97: 1019-1020. 2. Polanski LT et al. (2014) Reprod Biomed Online 28: 409-423.
We follow Definition of RIF
RIF is as the failure of clinical pregnancy
after 4 good quality transfers , with at least
3 fresh or frozen IVF cycles, in women under the age of
40
An Internationally agreed consensus on the definition is
yet to be reached
RIF is generally defined as the failure to achieve
clinical pregnancy after the transfer of two good
quality embryos, in at least three fresh or frozen
IVF cycles/embryo transfers (6 embryos in total) or
in at least two egg donations
(i.e., 4 embryos in total)
Ref:Hum Reprod. 2006 Dec;21(12):3036-43. Epub 2006 Aug 12.
Incidence of RIF
10- 40 %
• There is Scarcity of reported
Data that can accurately
represents the Incidence or
Prevalence.

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Thymosin Alpha 1 in Recurrent Implantation Failure : Dr Sharda Jain

  • 1. Thymosin Alpha 1 in Recurrent Implantation Failure Dr. Sharda Jain Lifecare IVF Center Gagan Vihar,, New Delhi, 110051
  • 2. When it comes to having a child, many people will exhaust any and all avenues – financial or geographic – to find a way around.
  • 3. Wide Variability In The Definition Of RIF To date there is a lack of a clear-cut consensus on the definition of RIF  Three generic definitions are considered according to: 1. Number of unsuccessful assisted reproduction treatment cycles 2. Number of embryos transferred 3. A combination of both factors Ref:1. Laufer N, Simon A (2012) Fertil Steril 97: 1019-1020. 2. Polanski LT et al. (2014) Reprod Biomed Online 28: 409-423.
  • 4. We follow Definition of RIF RIF is as the failure of clinical pregnancy after 4 good quality transfers , with at least 3 fresh or frozen IVF cycles, in women under the age of 40 An Internationally agreed consensus on the definition is yet to be reached
  • 5. RIF is generally defined as the failure to achieve clinical pregnancy after the transfer of two good quality embryos, in at least three fresh or frozen IVF cycles/embryo transfers (6 embryos in total) or in at least two egg donations (i.e., 4 embryos in total) Ref:Hum Reprod. 2006 Dec;21(12):3036-43. Epub 2006 Aug 12.
  • 6. Incidence of RIF 10- 40 % • There is Scarcity of reported Data that can accurately represents the Incidence or Prevalence.
  • 7. Prevalence of RIF  The incidence of pregnancy loss after natural implantation is high, estimated from 25% to 40%.  Of the total number of pregnancies that are lost, 75% represent a failure of implantation and are therefore not clinically recognized as pregnancies.  Failed implantation represents the major limiting factor in assisted reproduction.
  • 13. Assessment Of Causes Of RIF Is Crucial For Treatment
  • 14. Maternal Factors Anatomic Factor Endometrial Thickness & Receptivity Thrombophilia & Connective Tissue Disease Immunologic Factor
  • 15. Embryonic Factors Genetic Factor Embryo Ceases to Develop In Utero Male Factor Contribution
  • 16. Immune System Plays A Key Role In Successful Pregnancy Immune System Maternal-placental foetal crosstalk Embryo development & tropism Normal Implantation
  • 17. Innate Immunity Has A Major Representation At Materno-Foetal Interface  Most immune cells (70%) being CD56+ natural killer (NK) cells  Followed by 20% of monocytes  Between 10% to 15% of all cells found in the decidua are lymphocytes, mainly regulatory T cells (Treg)  Clonal expansions of allospecific uterine and peripheral Treg together with the proliferation of uterine natural killer cells (uNKs) and dendritic cells (DCs) are involved in the maintenance of immune tolerance to the foetus
  • 18. Pathophysiological Role Of Immunological Factors In RIF  Cytokine Imbalance  Expansion of peripheral natural killer cells  Deregulation of uterine natural killer cells  Allorecognnition: MHC molecules and NK cells receptors  Untreated hypothyroidism
  • 24. Thymosin Alpha 1 (TA1)  Synthetic peptidomimetic hormone of thymosin  28 amino acids  Thymosin secreted by the thymus  Modulates innate immunity - pleiotropic 24 Goldstein AL. History of the discovery of the thymosins Ann N Y Acad Sci. 2007;1112: 1– 13.
  • 25. Mechanism of Action 25 Immune dampening mechanism of action of Ta1. Thymosin alpha 1 has a feed-back dampening effect on the immune system, leading to increases in regulatory T cells and a decrease in the production of inflammatory cytokines. Thymosi n Alpha- 1
  • 26. Safety of Thymosin Alpha 1  Thymosin alpha-1 Molecule is available since 1979  Thymosin alpha is approved by USFDA and Approved in India by DCGI and 35 different countries.  Tried in more than 2,30,000 patients  2000+ published articles in pubmed  Thymosin alpha has been used in elderly patients upto 101 year old & children as young as 13 months without any significant side effects  Has been used for 12 months without any significant adverse event.  Very very low incidence of adverse effects Aliment Pharmacol Ther 15 2001, 1899±1905
  • 29. 29 MEAN OF DAY 1 AND EOT CRP (mg/L) DATA OF BOTH ACTIVE AND PLACEBO 62.96 26.79 0 10 20 30 40 50 60 70 Day 1 EOT MEAN CRP ACTIVE ARM Tα1 P value 0.039 62.5 5 84.8 5 0 10 20 30 40 50 60 70 80 90 Day 1 EOT MEAN CRP PLACEBO ARM
  • 30. 30 MEAN OF DAY 1 AND EOT FERRITIN(ng/ml) DATA OF BOTH ACTIVE AND PLACEBO 1073. 1 586.1 3 0 200 400 600 800 1000 1200 1400 1600 Day 1 EOT MEAN FERRITIN ACTIVE ARM Tα1 P value 0.018 1376. 9 1615. 3 0 500 1000 1500 Day 1 EOT MEAN FERRITIN PLACEBO ARM
  • 31. 31 MEAN OF DAY 1 AND EOT IL6 (pg/lL) DATA OF BOTH ACTIVE AND PLACEBO 213.95 103.14 0 100 200 300 400 500 600 Day 1 EOT MEAN IL6 P value 0.009 ACTIVE ARM (Tα1) 343.88 523.47 0 100 200 300 400 500 600 Day 1 EOT MEAN IL6 PLACEBO ARM
  • 32. 32 Kaplan–Maier graph on all-cause mortality among severe COVID-19 patients Statistically significant (pvalue – 0.03) difference between two arms has been observed with respect to All cause mortality , where Thymosin Arm has 11.1% Death rate compare to 38.5% in Placebo Arm, with absolute risk difference of 27.4%.
  • 33. Fig: Effect on thymosin on hospital days Conclusion: Thymosin Alpha 1 can lower death rate in severe COVID-19 patients, reduce the load on hospitals by shortening the required number of days of hospitalization and help in abbreviating the requirement of oxygen support by positively impacting the recovery rate and time taken for recovery.
  • 34. How Thymosin α 1 ( Tα1) reduces cytokine storm and ultimately reduces mortality in patients 1. Antagonizes activation induced (anti-CD3) and glucocorticoid- induced thymocyte apoptosis (CD3-causes apoptosis of CD4+ CD8+ Thymocytes through the activation of cAMP and Protein Kinase C) 2. Stimulates Indoleamine-2,3-Dioxygenase (IDO) activity 3. Increases FoxP3 producing regulatory T cells 4. Plays a role in feedback inhibition of cytokine production 5. Dampens immune response to prevent a pro-inflammatory cytokine storm Results. Genes associated with cytokine signaling and production were upregulated in blood cells from patients with COVID19, and the ex vivo treatment with Tα1-mitigated cytokine expression, Conclusion. These data suggest the potential role of Tα1 in modulating the immune response homeostasis and the cytokine storm in vivo.
  • 35. “Cytokine storm”, and inflammation-mediated severe lung damage and defective hemostasis are the main underlying reasons for morbidity and mortality in COVID-19 patients Tregs and their functions are compromised in severe COVID-19 patients engendering unrestrained immune cell activation. Victor E, Das M, Karnam A, et al. Potential of regulatory T cell-based therapies in the management of severe COVID-19. Eur Respir J 2020; in press (https://doi.org/10.1183/13993003.02182-2020). Tregs are in place to ensure that inflammation is kept in check. Current evidence suggests that the level of peripheral Tregs is prominently reduced in severely COVID Considering the importance of Tregs in immune homeostasis, reduction in the levels of Tregs could be one of the reasons for the hyperactivated immune system and damaged lungs in severe COVID-19 patients
  • 36. • Tregs inhibit the activation of both innate and adaptive immune cells via inhibitory surface molecules (like cytotoxic T lymphocyte antigen-4 (CTLA-4) and lymphocyte-activation gene-3) and secretion of immunosuppressive cytokines (IL-10, TGF-β and IL-35). • Tregs prevent inflammation-induced tissue damage during acute infections and to promote tissue repair as shown particularly in case of influenza infection model Victor E, Das M, Karnam A, et al. Potential of regulatory T cell-based therapies in the management of severe COVID-19. Eur Respir J 2020; in press (https://doi.org/10.1183/13993003.02182-2020).
  • 38. 38 Th1 IS PREGNANCY DISASTER Th1 IS PREGNANCY DISASTER Th2 IS PREGNANCY CONDUSIVE
  • 39. Th1 - Th2 • The Th1 response is characterized by the production of Interferon gamma (IFNγ), a powerful cytokine that helps to activate macrophages and other immune cells. • The main function of Th2 cells is to activate the antibody-mediated immune response. 39
  • 40. • The Th1 subset of CD4+ • T cells secretes cytokines usually associated with inflammation, such as IFN-gamma and TNF and induces cell-mediated immune responses. • The Th2 subset produces cytokines such as IL-4 and IL-5 that help B cells to proliferate and differentiate and is associated with humoral- type immune responses. 40 What is the difference between Th1 and Th2 CD4?
  • 41. 41
  • 43. Conclusion: Decreased maternal serum thymosin α1 levels may be associated with periconceptional endocrine and/or immune disturbances preceding miscarriage.
  • 45. Conclusion: ILT4+ DCs play an important role in the maintenance of immune tolerance during pregnancy, probably through the induction of Foxp3+ Treg cells, a process which is impaired in RM and RIF.
  • 47. Conclusion: Modulation of immune system in RIF patient is shifted to inflammatory responses as pNK cells, Th17 signaling pathway and TLR signaling pathway are activated.
  • 49. Conclusion: The imbalance between CD16- CD56dim and CD16- CD56bright uNK cells may have important functional implications in women with RIF and could be used as a diagnostic marker associated with endometrial quality.
  • 51. Conclusion: A combination of higher pro-inflammatory Th17 and exhausted Treg cells, and lower Treg and exhausted CD8+ T cells may co- exist in the peripheral blood of women with RIF.
  • 53. Conclusion: Cytokines play a role in controlling endometrial, decidual and cytotrophoblast cell function and defects in the expression of cytokines and/or their receptors are likely to result in implantation failure.
  • 54. Immunological Changes in Recurrent Implantation Failure (RIF) Effect of Thymosin Alpha 1 on Immunological Dysfunction in RIF Treg Cells ↓ Treg Cells ↑ Th1/Th2 ↑ Will bring to baseline CD56/CD57 ↑ CD56/CD57 ↓ NK cells - CD16-CD56 bright↑ NK cells - CD16-CD56 bright↓ NK cells - CD16-CD56 dim ↑ NK cells - CD16-CD56 bright ↓ PD-1↑ PD-1↓ PD-L1↑ PD-L1↓ ILT4+ DC ↓ ILT4+ DC ↑
  • 55. A Single-Center, Open-Label, Two-Arm Frozen embryo transfer, Randomized Study to Evaluate the Efficacy and safety of Thymosin α1 as an add-on therapy to standard of care (SOC) in Patients with Recurrent Implantation Failure.
  • 56. Study Title A Single-Center, Open-Label, Two-Arm Frozen embryo transfer, Randomized Study to Evaluate the Efficacy and safety of Thymosin α1 as an add-on therapy to standard of care (SOC) in Patients with Recurrent Implantation Failure. Phase Investigator Initiated Trial (IIT ) Indication Recurrent Implantation Failure(in patients who have are on in-vitro fertilization (IVF) treatment cycles) Study Design A Two-arm, Randomized Open-Label Study. Investigational Product Thymosin (Tα1) Dosage Regimen Total 37 doses  Before ET – Dosing at interval of 2 days gap ( 13 doses Embryo Transfe)  After ET (7 days gap) – Twice weekly dosing for 3 months (24 doses) Total number of subjects 20 subjects (10 – Arm 1 & 10 – Arm 2) Study duration (Treatment Duration + Follow up) 3.5 Months per subject OBJECTIVES ENDPOINTS Primary Objective 1) To evaluate the efficacy of Thymosin as an add-on treatment to SOC in patients with recurrent implantation failure. Primary Endpoint 1) Implantation rate Implantation rate is defined as the ratio of gestational sacs to the number of embryos transferred Time point:6 weeks after embryo transfer
  • 57. Secondary Objective 1) To evaluate the safety of Thymosin. Secondary Endpoints 1) Clinical pregnancy rate Clinical pregnancy will be determined as the presence of a gestational sac with heartbeats identified by vaginal or abdominal ultrasound Time point: 6 weeks after embryo transfer. 1) Ongoing pregnancy rate Ongoing pregnancy is defined when the pregnancy had completed ≥12 weeks of gestation. The ongoing implantation rate is defined as number of fetuses with heart activity beyond 12 weeks of gestation per transferred embryo. Time point: 12 weeks of gestation after embryo transfer 1) Biochemical pregnancy Biochemical pregnancy is defined as hCG levels > 5 on 2 occasions 15days or greater after hCG injection, with no gestational sac ever visible with ultrasound. Time point: On Day 14 after embryo transfer 1) All Adverse events including total number of Treatment-Emergent Adverse Event (TEAE) and Treatment-Emergent Serious Adverse Event (TESAE)
  • 58. ELIGIBILITY CRITERIA Inclusion criteria 1) Female participants between 20 to 40 years of age; 2) Infertile women with a history of recurrent implantation failure who had failed to achieve a clinical pregnancy in which at least four good-quality embryos were transferred; 3) Female participants who had at least two *top-quality embryos appropriate for embryo transfer (*Top-quality embryos were defined as day-2 embryos having four or more equally sized and shaped blastomeres, with <10% fragmentation without multinucleation1) 1) Female Participant with known ART failures or implantation failure that warrants no further ART program feasible. Exclusion criteria 1) Female Participant having any endometrial disease 2) Female Participant who have participated in another trial with an investigational drug within 1 month prior to this trial. 3) Female Participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol 4) Female Participant with any other clinically significant illness in the opinion of the investigator that may jeopardize the study results.
  • 59. Randomization All the enrolled subjects shall be randomized into twoarms: Frozen Embryo Transfer Arm – 1: Frozen Embryo Transfer with Thymosin + SOC Arm – 2: Frozen Embryo transfer + SO Statistical analysis Shall be planned once the objectives and endpoints are finalized
  • 60. Dosing Schedule of thymosin Alpha 1 + SCO for fresh Embryo Transfer Total Injection of thymosin Alpha 1 -37 Induction Phase
  • 61. Dosing Schedule of thymosin Alpha 1 + SCO for fresh Embryo Transfer Total Injection of thymosin Alpha 1 -37 Induction Phase
  • 65. Parameters Recorded Sr. No. Parameters Before Administration of Thymosin Alpha 1 On the Day After Administration of Last Dose of Thymosin Alpha 1 1 Treg Cells 4 Th1/Th2 5 PD-1 6 CD56/CD57 ↑ 7 NK cells - CD16-CD56 bright/dim 8 Biochemical Pregnancy Rate NA 9 Clinical Pregnancy Rate NA 10 Ongoing Pregnancy Rate NA