Regenerative medicine study software for clinics and cell therapy sites

Regenerative medicine covers a wide range: platelet-rich plasma, bone marrow concentrate, adipose-derived preparations, culture-expanded mesenchymal stromal cells and, increasingly, tissue-engineered products. The studies that include them range from a clinic running an observational registry of knee osteoarthritis patients, to an investigator-sponsored trial under an Investigational New Drug application, to a company-sponsored randomised study with a sham or active comparator. The data requirements differ, but three things appear in every case: a clear definition of the intervention, outcome measures collected at the same time points for everyone, and a safety record that stands up to review.

The regulatory context matters here more than in most fields. In the United States, human cells and tissue products are regulated under a tiered framework. Lower-risk products must meet a four-part test under 21 CFR 1271.10: minimal manipulation, homologous use, no combination with another article, and no systemic effect or dependence on the metabolic activity of living cells, with some exceptions. Products outside that test generally need premarket review, and a designation such as RMAT exists for serious or life-threatening conditions. How a particular product and claim fit is a question for regulatory counsel and FDA, and the site’s marketing statements can affect it. This page does not interpret those rules and Capture does not certify any product’s status.

What software can do is make the study defensible whatever its regulatory route. If you are building toward an IND, an FDA IND application guide explains the academic route. For full-scale cell and gene therapy programmes with manufacturing and conditioning, see EDC for cell and gene therapy trials; this page is for the site-level study around musculoskeletal, aesthetic and wound-care use of cell-based products.

Clinics sometimes begin collecting outcomes as a quality project and later want to publish. That change matters: research with human participants generally needs ethics review, and consent has to say what the data will be used for. Decide early whether the study is a registry, an interventional trial or an approved expanded access programme, and what review applies. The IRB glossary entry explains the role, and the orthopaedic outcomes registries page and osteoarthritis trials page describe the data structure for the most common indications.

Keep the roles separate. The treating physician, the outcomes assessor and the person who analyses the data should not all be the same person if blinding matters. Capture separates researcher, site coordinator and admin access and can hide treatment-arm values from blinded roles; the blinded and unblinded role management page shows how. A field-level audit trail records every change with the reason, which helps when a reviewer asks why a score was edited.

Multi-clinic networks are common in this field. If several clinics contribute to the same registry, multi-site clinical trial management describes site-level numbering and by-site exports, and clinical trial software for clinical research networks covers the network view.