Regenerative Medicine:
Tissue Engineering
Standards Come to ASTM

In the field of biomedicine, 37 new standards are under development by ASTM Committee F04 on Medical and Surgical Materials and Devices, Division IV on Tissue Engineered Medical Products. They cover tissue-engineered medical products and their components used in biomedical and pharmaceutical industries—the broadest focus in the field of regenerative medicine at this time, according to Division IV Vice-Chair Grace Lee Picciolo, Ph.D., a cellular biologist with the U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Technology, Rockville, Md.

“Tissue engineering involves cell and tissue repair and regeneration,” Picciolo says, “by providing scaffolds as substrates and bioactive molecules as signals to the cells.” She comments about a recent news report on the reconstruction of a frostbitten nose: “Tissue engineering has enabled this type of shaping of the repaired tissue. Engineered living cellular constructs can result in the controlled replacement of damaged or lost tissue,” she confirms.

Division IV on Tissue Engineered Medical Products was formed in 1997 and has had from 85 to 130 members involved in meetings and activities. “We’ve progressed to establish a structure for our division that includes 10 subcommittees, and 37 task groups,” says Picciolo, who with colleagues brought a focus on tissue engineering to the FDA in 1994, and subsequently joined ASTM to develop standards.

“Tissue engineering was a newly developing field in the biomedical research and development arena. It became obvious that when biological cells could be made to respond to materials—to use the materials as a support and reservoir of signaling molecules and propagate—the development of medical applications would follow. Thus, we saw the need for standards for product development and regulatory approval.”

“The Center for Devices and Radiological Health had previously been closely allied with ASTM Committee F04 through their medical devices standards. So it was suggested that we should approach ASTM when we were looking for a standards organization that had a process in place,” avers Picciolo.

The division’s documentation of the use of important components for tissue-engineered medical products has progressed steadily. “Two companies in the alginate field, one from Norway and one from the United States, have contributed their research and expertise to the ASTM standards effort,” Picciolo notes. “They have produced purified alginates from marine seaweed since the 1990s. Jump-started by this information, the Alginate Task Group, co-chaired by Dr. Michael Dornish, is finalizing an alginate standard, and moving on to one for chitosan.”

“Alginate is used in final products for drug delivery, via encapsulated cells or bioactive substances, impression materials for dental applications, and as a bulking aid to help prevent urinary incontinence,” explains David Kaplan, Ph.D., a microbiologist/cell biologist also with the FDA OST and task group co-chair.

Among many drafts, Division IV has an approved standard and two drafts near completion:

• F 2027, Guide for Characterization and Testing of Substrate Materials for Tissue Engineered Medical Products;

• Draft Standard Guide for the Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Products Applications; and

• Draft Standard Test Method for In Vitro Biological Activity of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) Using the W-20 Mouse Stromal Cell Line.

For further technical information, contact Grace Lee Picciolo, FDA CDRH, OST (301/827-4755), David Kaplan FDA, CDRH, OST (301/827-4754) or Michael Dornish, ProNova BioMedical, Gaustadalleen 21, Oslo N0371, Norway (472/295-8650). Committee F04 meets Nov. 15-17 in Orlando, Fla. For meeting or membership details, contact Staff Manager Teresa Cendrowska, ASTM (610/832-9718). //

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