provided during the inspection, the documents that were given to the investigators, and all cor-respondence with FDA since the inspection, including this unredacted letter (with all attach-ments), are confidential business records exempt from public disclosure under 5 USC 552(b)(4).Please limit access to those confidential business records to only those FDA personnelwho must have access to this body of information to perform their duties. Consistent with 5USC 552(b)(4), FDA must contact Celltex prior to any public disclosure of the confidential busi-ness records, informing it of the details of the proposed disclosure.Celltex is providing a redacted version of this letter (
). It requests that FDA postthe redacted version of this letter without any attachments as Celltex’s response to the Sep-tember 24 Letter on FDA’s website.
Request for a Meeting
Celltex respectfully requests a meeting pursuant to 21 CFR 10.65(c) to discuss the fol-lowing issues identified in and questions arising from the September 24
FDA has identified the adipose tissue from autologous donors as the “humancell, tissue, cellular or tissue-based product” (HCT/P) at issue, not the constituentmesenchymal stem cells (MSCs);
Why is the adipose tissue being treated differently by FDA than other re-covered tissue from which HCT/Ps are isolated in compliance with1271.10, such as umbilical cord blood or semen?
If MSCs were removed from other sources such as bone marrow or pe-ripheral blood, how would that affect the application of 1271.10? Wouldthose MSCs become the HCT/P against which 1271.10 is applied?
Celltex’s April 27
Letter (resubmitted here as
) showed the original,relevant fundamental characteristics of the MSCs are not altered (under 21 CFR1271.3(f)(2)) in any of the steps used by RNL;
Does FDA agree that the relevant characteristics of MSCs are identified inCelltex’s April 27
Letter (morphology, immune-phenotype, differentia-tion capability, and genetic stability)? If not, what other characteristicsnecessary to define MSCs are relevant?
Does FDA agree that the techniques described in the April 27
Letter fortesting those characteristics are the appropriate tests for those charac-teristics (see page 6-7 of April 27 Letter)? If FDA prefers other tests,
As explained below, Celltex could change the recovered tissue from which MSCs are isolated. Adipose tissue isused because it is a relatively convenient procedure for the individual and offers a plentiful supply of MSCs relativeto the volume of tissue removed compared to other sources of MSCs.