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# ISCT Criticizes Ruling in Cell, Gene Therapy Case
- URL: https://www.fdaweb.com/isct-criticizes-ruling-in-cell-gene-therapy-case/
- Published: 2022-09-13T12:00:00.000Z
- Updated: 2026-09-14T17:59:05.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5152721

The International Society for Cell & Gene Therapy (ISCT) says a recent California federal court [ruling](https://www.fdaweb.com/fda-loses-california-stem-cell-treatment-case/) in favor of the California Stem Cell Treatment Center and against FDA “is flawed and has inserted regulatory uncertainty into the cell and gene therapy market, creating opportunities for clinics offering purported treatments that are scientifically unproven and potentially dangerous to patients.” An ISCT [statement](https://www.isctglobal.org/telegrafthub/blogs/lauren-reville/2022/09/12/isct-issues-response-to-us-federal-judge-ruling-on?ref=fdaweb.com) says the ruling that FDA has no jurisdiction over the California Stem Cell Treatment Center’s products contains scientific inaccuracies that may have affected the judge’s ruling.

The ISCT Committee on the Ethics of Cell and Gene Therapy says examples of statements in the decisions that are problematic and unfounded are:

- statements about stromal vascular fraction that are both inaccurate and unsupported by current scientific knowledge;
- the assertion that the clinical networks involved in the suit use FDA-authorized devices to produce autologous stem cell-based interventions does not recognize that the devices in question may not have been authorized by FDA or authorized for other purposes and have not been designed for the production of stem cell therapies; and
- the statement that culture-expanded mesenchymal stem cells should not be regulated as drugs conflicts with scientific evidence, which “opens the door to unchecked administration of poorly characterized and non-standardized cell preparations with unknown safety and efficacy and may pose significant risks to patients.”