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# Histogen Notified of FDA Clinical Hold on IND Trial
- URL: https://www.fdaweb.com/histogen-notified-of-fda-clinical-hold-on-ind-trial/
- Published: 2021-01-20T12:00:00.000Z
- Updated: 2026-09-14T16:43:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148488

FDA reportedly has verbally notified Histogen that the agency has additional questions about the company’s IND application package for a planned Phase 1/2 clinical trial of its HST-003, intended to evaluate the safety and efficacy of human extracellular matrix implanted within microfracture interstices and the cartilage defect in the knee to regenerate hyaline cartilage in combination with a microfracture procedure. The company [says](https://www.marketwatch.com/press-release/histogen-reports-fda-clinical-hold-for-planned-phase-12-trial-of-hst-003-for-knee-cartilage-regeneration-2021-01-19-161841953?tesla=y&ref=fdaweb.com) it expects to receive written notification from FDA by 2/12\. It says it understands that the clinical hold is due to pending CMC information that is required to complete the agency’s review.