RegenMedTrials is a data sharing platform designed to collect, analyze, and share de-identified information on outcomes of people treated with Regenerative Medicine and Advanced Therapies (RMAT).

RMAT include cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies or products, except for those regulated solely under Section 361 of the Public Health Service Act and part 1271 of Title 21, Code of Federal Regulations (U.S.A). RMAT are intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition. Preliminary clinical evidence for RMAT indicates that the agent has the potential to address unmet medical needs for such disease or condition. For additional details on RMAT, see the FDA RMAT designation.

We are counting on robust participation and collaboration. We hope to capture de-identified information from the majority of RMAT clinical trials registered in ClinicalTrials.gov and in the WHO’s International Clinical Trial Registry Platform (see Lancet 2007; 369: 1909–11). The platform will facilitate analyses and meta-analyses on the impact of RMAT in a spectrum of trial participants and conditions. The platform will also enable protocol standardization, international collaboration, and analyses on factors such as age, comorbidities, concurrent treatments, ethnicity that could be associated with RMAT outcomes.

RegenMedTrials is currently accepting proposals for data sharing , data accessing, and partnership.
Please contact us at datasharing@regenmedtrials.org and include a link to one or more of the following: your ORCID iD, My Bibliography (PubMed), Google Scholar Profile, ResearchGate, Institutional webpage, or LinkedIn profile.