> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Regenerative Therapies Outcome Measures Needed: Report
- URL: https://www.fdaweb.com/regenerative-therapies-outcome-measures-needed-report/
- Published: 2019-12-10T12:00:00.000Z
- Updated: 2026-09-14T15:56:06.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5145697

A report by the Alliance for Cell Therapy Now says there is a need for a national effort to measure outcomes related to regenerative cell therapies, as well as increased federal funding for National Institutes of Health research and expanded capacity at FDA to support the rapidly growing field. The [report](https://www.marketwatch.com/press-release/new-report-calls-for-measurement-of-outcomes-and-federal-funding-for-research-and-increased-capacity-at-fda-to-advance-safe-and-effective-regenerative-cell-therapies-2019-12-10/print?ref=fdaweb.com) is based on insights shared by several leaders during a September event hosted by the alliance in collaboration with the Regenerative Medicine Foundation and the Cord Blood Association.

The report says regenerative cell therapies represent the next generation of treatments that are showing great promise in cardiology, neurology, oncology, orthopedics, and wound healing. “Several well-designed clinical trials are now being conducted under FDA-approved investigational new drug protocols,” it says. “At the same time, some clinics have caused patient harm or made questionable claims, taking advantage of vulnerable patients and casting a negative light on this promising field.”

Among the steps called for is increased CBER capacity to respond to the growing pipeline; provide additional education, dialog, and technical assistance for academic and research institutions, industry innovators, and practitioners, to increase understanding of and compliance with new regulations; and increased enforcement activities against those clinics that are causing patient harm.