Program seeks Council approval for an initiative titled “Bioprinted Tissue Constructs for OB/GYN and Pediatric Applications.”
Regenerative Medicine is emerging as a new frontier of therapeutics aimed at restoring physiological tissue and/or organ function impaired due to genetics, injury or toxicity. It involves trans-disciplinary efforts (namely, stem cells, tissue engineering, biomaterials) to develop novel therapies for ameliorating the prognosis and/or quality of life of individuals currently with no or only palliative treatment options. Additive manufacturing (a.k.a., 3D printing) consists of depositing successive layers of raw materials to obtain 3D structures produced using digital Computer Aid Design (CAD) or Magnetic Resonance Imaging (MRI). This allows manufacturing patient-specific constructs – highly desirable for functional restoration of anatomical structures requiring adaptation and remodeling (i.e., pediatrics, and pelvic / reproductive organs). Optimization of 3D printing protocols that incorporate biologics, small molecules, cells, and biomaterials into implantable tissue constructs (a process called bioprinting) is enabling new applications previously cumbersome to design and manufacture.
Unfortunately, the clinical translation of bioprinted tissue constructs is currently hampered by lack of regulatory and entrepreneurial expertise of innovators, challenges of clinical-grade manufacturing, along with complexity of evidence-generating clinical studies, particularly in the special patient populations within NICHD’s priorities.
The last cycle of this initiative was focused on 3D printed implantable devices to address the need for adaptation of growing children. Seven initial R21 awards were made, 4 of which advanced to the R33 phase. Encouraging progress have been reported with tissue construct optimization and testing in preclinical models – and some of the technologies reaching maturity to move to first-in-human testing. However, much remains to be done to enable the translation of bioprinted tissue constructs to clinical testing.
This initiative intends to help identifying and working to overcome current barriers to preclinical product development, validation and verification, ultimately enabling evidence generation for regulatory approval and human testing of mature bioprinted tissue constructs addressing the unmet needs of NICHD mission-relevant gynecologic, obstetric and pediatric diseases and disorders.
The proposed concept aligns with NICHD Strategic Plan 2020 Scientific Research Theme 5 “Advancing Safe and Effective Therapeutics and Devices for Pregnant and Lactating Women, Children, and People with Disabilities,” as well as with Scientific Research Theme 2 –Initiative 2.4.4 “Support development of bioengineered tissues for uterine function restoration, uterine reconstruction, and vagina.”
The proposed concept aligns with the OPPTB research priorities and synergizes with other NICHD branches (e.g., GHDB and FIB), as well as NIH Institutes and Centers that support innovation in the medical device and regenerative medicine space.
Program Contact
Antonello Pileggi
Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB)
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