Table. 1 NEC-ACCELERATOR partners.

From: Translating regenerative medicine therapies in neonatal necrotizing enterocolitis

 

Discipline/Body

Reasons for inclusion

1

Parents/Caregivers

To incorporate the perspective, concerns, and preferences of those directly affected, from clinical trial design to implementation of study results

2

Nursing

To ensure proper care, communication, and patient management during trials

3

Basic Science (stem cell biology, intestinal epithelial biology, and immunology)

To provide foundational knowledge and research expertise in NEC and stem cell therapies

4

Clinicians (neonatologist and pediatric surgeon)

To offer specialized knowledge in neonatal care and management of NEC and potential integration of stem cell therapies

5

Trials methods

To design efficient, adaptive clinical trials that generate the evidence for safety and efficacy needed to inform treatment decisions

6

Biostatistics

To provide statistical analysis and design support for trials

7

Research ethics

To address ethical challenges and considerations in neonatal clinical trials

8

Regulatory compliance

To navigate regulatory processes, guidelines, and requirements

9

Health economics

To evaluate financial viability and inform decision-making related to stem cell therapies

10

Industry partner (Micregen Ltd)

To collaborate in the development of standardized stem cell products and manufacturing processes

11

Implementation science

To facilitate effective adoption and integration of stem cell therapies in NEC management

12

Broadcasting and communication

To aid in disseminating information, raising awareness, and fostering communication among Partners

13

Patient-centered organizations (Canadian Neonatal Network and NEC Society)

To offer “lived experience” insights and trauma-informed care practices, advocate, and support research and translation of therapies