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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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PureGen™ Osteoprogenitor Cell Allograft, Parcell Laboratories, LLC - Untitled Letter

June 23, 2011

 
VIA UPS
  
Ms. Pamela G. Layton
Chief Executive Officer
Parcell Laboratories, LLC
153 Needham Street, Bldg. 1
Newton, MA 02464-1505
 
Dear Ms. Layton:
 
During an inspection of your firm, Parcell Laboratories, LLC, and your contract manufacturing organization, New England Cryogenic Center (NECC), both located at 153 Needham Street, Newton, MA, from February 9 to 14, 2011, the Food and Drug Administration (FDA) learned that your PureGen™ Osteoprogenitor Cell Allograft (ELA® cells) are unrelated allogeneic -----(b)(4)----- cells -------------(b)(4)-------------- and then cryopreserved. The source of the cells is --------------------------(b)(4)--------------------- of osteoarthritic patients. Inspectional records reviewed were standard operating procedures, product summaries, instructions for use, medical and health history profiles, donor physical assessments, viral test results, fungal test results, sterility test results, eligible donor files, and ineligible donor files.
 
The PureGen™ Osteoprogenitor Cell Allograft: Instructions for Use state that, “This product is intended for homologous use for the repair, replacement, reconstruction of musculoskeletal defects. The product is for homologous use only and is not to be used systemically.” Additionally, in your Summary of the ELA Regenerative Cell, you describe three key components of the tissue repair process: “The first component involves the suppression of cytokines that cause tissue swelling and scar formation. When ELA cells are placed in close proximity to cells that release damaging cytokines, the production of these cytokines dramatically decreases. The second component responds to the trauma by releasing factors that promote blood vessel formation and prepare the tissue injury site for cellular growth. The third component involves reconstructing the natural tissue architecture with like cells.” Furthermore, the ------(b)(4)----- Stem Cell Collection Program pamphlet states that, “The -----(b)(4)-----, drawn from the patient will be sent to Parcell™ Laboratories for processing and the ELA® cells may be used by a leading spine company for bone regeneration therapeutics in patients unrelated to the donors.” 
 
These ELA® cells from ------(b)(4)-----are human cells, tissues, or cellular and tissue-based products (HCT/Ps) as defined in 21 CFR 1271.3(d). However, this ---(b)(4)--- cell product is a HCT/P that does not meet all of the criteria in 21 CFR 1271.10(a) and therefore is not regulated solely under section 361 of the Public Health Service Act (PHS Act) and the regulations in 21 CFR Part 1271. Specifically, the product does not meet the criterion in 21 CFR 1271.10(a)(4)(ii)(b) because the product is dependent on the metabolic activity of living cells for its primary function and is not intended for autologous use or allogeneic use in a first or second degree blood relative. As a result, your ELA® cells are drugs under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)] and biological products as defined in section 351(i) of the PHS Act [42 U.S.C. 262(i)].
 
Please be advised that in order to introduce or deliver for introduction a drug that is also a biological product into interstate commerce, a valid biologics license must be in effect [21 U.S.C. 355(a); 42 U.S.C. 262(a)]. Such licenses are issued only after a showing of safety and efficacy for the product’s intended use. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug (IND) application in effect as specified by FDA regulations [21 U.S.C. 355(i); 21 CFR Part 312). The PureGen™ Osteoprogenitor Cell Allograft is not the subject of an approved biologics license application (BLA) nor is there an IND in effect. Based on this information, we have determined that your actions have violated the Act and the PHS Act.
 
This letter is not intended to be an all-inclusive review of the products that your firm may promote and/or market. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and the PHS Act and their implementing regulations.
 
We request that you notify this office, in writing, of the steps you have taken or will take to address the violations noted above and to prevent their recurrence. Your response should be sent to me at the following address: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Suite 200 N, Rockville Maryland 20852-1448.
 
If you have any questions regarding this matter, you may contact Ms. Shannon Aldrich at (301) 827-6201. Please be advised that only written communications are considered official.
Sincerely,
 
Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
 
cc:        Mr. John R. Rizza
Chief Executive Officer
New England Cryogenic Center
153 Needham Street, Bldg. 1
Newton, MA 02464-1505