Why This Study Matters for Minimal Manipulation
For structural HCT/Ps, FDA focuses on whether processing preserves the tissue’s original relevant characteristics—those that provide cushioning, support, and load distribution. By imaging umbilical cord tissue (specifically – Wharton’s jelly “WJ”) both pre- and post-processing, this study evaluates whether the collagen microarchitecture, fiber orientation, and cross-linked extracellular matrix remain intact after manufacturing.
Study Overview
The study examined human umbilical cord tissue allografts using scanning and three-dimensional electron microscopy at multiple magnifications. Collagen fiber networks were evaluated qualitatively and quantitatively, with specific attention to fiber diameter, orientation, and overall ECM organization before and after processing.
Pre- and Post-Processing: What the Images Show
Electron micrographs demonstrated a dense, multidirectional, cross-linked collagen network in native Wharton’s Jelly. Post-processing images showed preservation of this architecture, with collagen fiber diameters remaining within the same physiological range and only minor variation consistent with hydration effects. The extracellular matrix scaffold remained structurally comparable before and after processing.
Minimal Manipulation and Homologous Structure
The preserved collagen network and ECM scaffold support Regenative Labs’ position that its WJ allografts remain structurally Wharton’s Jelly and are processed in a way that does not alter their original relevant characteristics. Comparisons with published electron micrographs of cartilage and fascia further underscore the structural similarity between WJ and native load-bearing connective tissues, aligning with its intended use as a structural allograft.
What This Means for Clinicians and Regulators
This electron microscopy work provides objective, image-based objective evidence that Regenative Labs’ processing preserves the structural properties of Wharton’s Jelly. For clinicians, it clarifies that these products are positioned as connective tissue supplements rather than cell-based therapies. For regulatory and research partners, it offers a data-driven foundation for discussions around minimal manipulation and homologous, structural use.
Read the Full Study
Access the complete electron microscopy report to review methodology, imaging panels, and quantitative analyses in detail.