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# MaaT013 Clinical Hold Still in Place
- URL: https://www.fdaweb.com/maat013-clinical-hold-still-in-place/
- Published: 2022-08-11T12:00:00.000Z
- Updated: 2026-09-14T17:55:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152487

FDA has informed France’s MaaT Pharma that its clinical hold on the company’s IND for a Phase 3 trial of its MaaT013 drug candidate in patients with steroid-resistant acute graft-versus-host disease remains in place. MaaT [says](https://www.maatpharma.com/august-10-2022-maat-pharma-announces-update-on-u-s-fda-investigational-new-drug-application-for-maat013-in-patients-with-acute-graft-versus-host-disease/?ref=fdaweb.com) FDA acknowledged that it received satisfactory answers from the company on multiple clinical and manufacturing-related questions that FDA had raised. FDA now also wants information on the safety and efficacy of MaaT’s pooling approach that involves mixing donations from multiple donors to achieve higher richness, diversity, and better standardization of the product. MaaT says it also is evaluating additional agency recommendations about the trial.