From the Guidelines

Exosome therapy is not FDA-approved for use in pregnancy, and its efficacy and safety in this context are unknown.

The provided evidence does not discuss the use of exosome therapy in pregnancy, but rather its potential applications in other areas, such as cardiac diseases, cancer, and immune-modulatory therapies 1.
There is limited information on the success rate of exosome therapy, but a phase I trial using autologous dendritic cell-derived exosomes loaded with tumor antigens did not induce detectable effector T cell responses, although a positive effect on natural killer cells was observed in some patients 1.

The FDA approval status of exosome therapy is not mentioned in the provided evidence, but it is clear that exosome therapy is still in the early stages of research and development.
The evidence suggests that exosome therapy may have potential as a therapeutic option for various diseases, but further studies are needed to fully understand its efficacy and safety, particularly in the context of pregnancy.
The lack of information on exosome pharmacokinetics in vivo and the ideal route of administration are significant concerns that need to be addressed before exosome therapy can be considered for use in pregnancy 1.

From the Research

Exosome therapy has shown promising potential in treating preeclampsia, a common morbid complication during pregnancy, by regulating immune responses, cell proliferation, and angiogenesis 2.
Mesenchymal stem cell-derived exosomes (MSC-Exos) have been found to participate in various important physiological processes, including immune regulation, cell proliferation, and migration, and have shown potential in tissue repair and disease treatment 2.
Exosomes have also been found to play a crucial role in maintaining immune homeostasis between the mother and developing fetus, and their concentration and size have been studied as potential diagnostic markers for adverse pregnancies such as preeclampsia, gestational diabetes mellitus, and preterm premature rupture of membrane 3.

There is no direct evidence of FDA approval for exosome therapy in pregnancy, as the current research is primarily focused on the potential therapeutic applications and mechanisms of exosomes in pregnancy-related diseases 2, 3, 4, 5, 6.

Exosomes have been explored as potential therapeutic agents for various pregnancy-related diseases, including preeclampsia, gestational diabetes mellitus, and recurrent spontaneous abortion 2, 3, 4.
The success rate of exosome therapy in pregnancy is still being researched, and more studies are needed to determine its efficacy and safety in clinical settings 5, 6.

Exosomes have been found to be effective in regulating gene expression, influencing mRNA stability, and acting as competitive endogenous RNAs to bind miRNAs, making them important in intercellular communication and signal transduction 4.
Exosomal lncRNAs have been found to exist indefinitely and can accurately and timely reflect the progression and regression of pregnancy-related diseases, making them potential diagnostic biomarkers 4.