A peer-reviewed data compilation initiative on evidence-based regenerative medicine protocols studied in elite athletes — for Investigational New Drug and Institutional Review Board purposes only.
AIA Pro compiles published, peer-reviewed clinical and translational data on orthobiologic and cell-based therapies in professional and elite athletic populations. The compiled dataset is intended to support sponsor and investigator submissions to the United States Food and Drug Administration and to Institutional Review Boards in connection with Investigational New Drug (IND) applications and IRB-approved research protocols.
The professional athlete population represents an unusually well-documented cohort for regenerative medicine research. Imaging, biomechanical telemetry, recovery timelines, and return-to-play outcomes are tracked with rigor seldom available in general orthopedic care.
AIA Pro applies machine-augmented analysis to peer-reviewed publications, public clinical-trial registries, and de-identified team medical records (where IRB consent and HIPAA waivers permit) to compile structured datasets supporting:
AIA Pro does not provide medical care, does not treat athletes, and does not make clinical recommendations. Its work product is structured data: literature catalogs, protocol abstracts, outcome registries, and IND-supporting summaries delivered to sponsors and IRBs under formal research agreements.
"Evidence is upstream of practice. AIA Pro exists to compile the evidence, not to apply it."
Every entry in the AIA Pro catalog is sourced from one of the following:
PubMed, MEDLINE, Cochrane, and journal repositories. DOI-anchored. Quality scored by AMSTAR 2, GRADE, or comparable framework where applicable.
ClinicalTrials.gov, EU CTR, ANZCTR. Trial status, sponsor, and outcome data extracted under each registry's open-data terms.
FDA guidance, RMAT designations, advisory committee meeting minutes, 510(k) and BLA summaries available through openFDA and FDA dockets.
In the United States, the use of regenerative medicine therapies in elite athletes is governed by FDA regulations on human cells, tissues, and cellular and tissue-based products (HCT/Ps) under 21 CFR Part 1271, and by the public health service Act sections governing biologic licensure under 351(a) of the PHS Act.
Use of any therapy that does not meet the criteria for an exception (homologous use, minimal manipulation, non-systemic effect, autologous same-day use under the surgical procedure exemption) requires an active Investigational New Drug (IND) application and IRB-approved research protocol.
AIA Pro's research output is designed to support sponsors and investigators in preparing IND applications and IRB protocol packages with cataloged, source-cited evidence on indication-specific outcomes. The site does not facilitate, recommend, or enable any clinical use of investigational therapies outside this regulatory framework.
AIA Pro engages with IND sponsors, principal investigators, IRBs, regulatory consultants, and academic medical centers under formal research and data-use agreements. We do not engage with patients, athletic agents, team medical staff seeking off-label clinical guidance, or any party seeking clinical recommendations.