Clinical trials for cellular, acellular and matrix-like products (CAMPs): an evidence consensus
DOI:
https://doi.org/10.63676/r8d7vm21Abstract
As Chair of the evidence consensus panel, I had the pleasure of convening the nation’s top experts in the field of wound healing on August 1, 2025, in Washington D.C.. The goals for the expert panel were twofold: 1) to address the evidence gap around the efficacy of cellular, acellular, and matrix-like products (CAMPs) in the treatment of nonhealing wounds and 2) to develop guidelines for the conduct of CAMP clinical trials. In 2024, the Medicare Administrative Contractors (MACs) published nearly identical Local Coverage Determinations (LCDs) requiring clinical trial evidence for reimbursement of CAMP products for diabetic foot and venous leg ulcers. The LCDs analyzed the available evidence for CAMPs and, based on their review, approved several products. After several delays, the MACs require products not on the list to submit peer-reviewed evidence submissions by November 1, 2025.
I applaud CMS and the MACs for their reliance on clinical trial evidence; however, few of the patients enrolled in the approved RCTs published to date would meet the LCDs' requirements for medical necessity. Moreover, the LCDs do not provide any guidance on trial design or conduct to guide future research. The purpose of this evidence consensus is to define a practical, rigorous evidentiary bar spanning run-in requirements, consistent standard of care, pre-trial statistical analysis plans, validated clinical endpoints, complete datasets, and data transparency. In this way, investigators, sponsors, journals, and payers can align on what constitutes credible proof of benefit.
The implications of publishing this consensus are immediate and material: it creates a uniform template for trials intended to support Medicare coverage, improves comparability across products, reduces bias and opaque practices, and prioritizes outcomes that matter to patients and clinicians. By articulating standards that reflect current best practice and analytic methods, this consensus gives CMS and the MACs a defensible basis for reimbursement decisions while accelerating access to effective CAMPs for beneficiaries and steering industry investment toward studies that will withstand regulatory and peer scrutiny.
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