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# FDA ‘Lacks Resources’ for Stem Cell Regulation: Report
- URL: https://www.fdaweb.com/fda-lacks-resources-for-stem-cell-regulation-report/
- Published: 2019-02-28T12:00:00.000Z
- Updated: 2026-09-15T01:08:55.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, #legacy-id-D5143491

FDA officials say the agency lacks the resources needed to pursue a comprehensive crackdown on the growing private stem cell industry. Responding to a lengthy *Washington Post* investigative [report](https://www.washingtonpost.com/national/health-science/miraculous-stem-cell-therapy-has-sickened-people-in-five-states/2019/02/26/c04b23a4-3539-11e9-854a-7a14d7fec96a%5Fstory.html?utm%5Fterm=.0b12c15eef87&ref=fdaweb.com) reviewing cases of several people who have been hospitalized after being injected with products made from umbilical cord blood, FDA commissioner **Scott Gottlieb** said it is difficult to impose a “regulatory architecture after an industry has sort of grown up.”

The article also quotes former CBER official **Mark Schwartz** that “there’s now a marketplace where arguably hundreds of millions of dollars are being made.” Schwartz said that manufacturers, clinics, and distributors like Liveyon, the Yorba Linda, CA, facility that is the main subject of the article, “have a vested interest in keeping this going and are not easily scared off.”

Products made from umbilical cord blood, which the *Post* describes as a little-known but fast-growing segment of the booming stem cell industry, have hospitalized at least 17 people according to state and federal health officials and patient report,” the article says. “Sold as a miracle cure for a variety of intractable conditions,” the report says, “the injections have sickened people in five states, prompting new warnings from health officials about the risks of unproven stem cell treatments.”

A Centers for Disease Control and Prevention report at the end of 2018 tied 12 cases in multiple states to treatments sold by Liveyon. And the newspaper says three additional patients in Texas and Maine have sued the company, saying its products infected them with bacteria.

Founded in 2016, the article says, Liveyon sells tiny vials of a solution it says is derived from umbilical cord blood, which it claims is an especially potent source of healing stem cells. Although the products are not approved by federal regulators or supported by clinical research, the *Post* says, businesses selling them say they provide relief to many patients. The article says many scientists say the injections, like most stem cell therapies, violate FDA rules against marketing unapproved drugs and are potentially dangerous.

Company officials told the newspaper it would have taken too long to establish their own manufacturing operation and so turned to Exeligen Scientific in San Diego, CA. Exeligen set up Genetech in San Diego to produce Liveyon’s vials.

A 6/18-6/22 FDA [inspection](https://www.fdaweb.com/multiple-violations-at-genetech-umbilical-cord-blood-facility/) at Genetech found multiple violations of human cell, tissue, or cellular or tissue-based product regulations in the firm’s processing of human umbilical cord blood. The agency issued an 11/29/18 Warning Letter noting that the products are regulated as drugs and biological products and that Genetech did not have an approved BLA or IND in effect. The letter also said there were significant deviations from current good manufacturing practice and current good tissue practice. “The deviations in manufacturing practices observed as well as those noted in documents collected during the inspection indicate that the use of your products raises potential significant safety concerns,” the Warning Letter said. It said FDA had received “numerous reported safety concerns involving your products.”

The *Post* was unable to obtain comment from anyone at either Exeligen or Genetech, noting that the phone numbers and Web sites for the companies are no longer active. The Liveyon CEO was copied on the FDA Warning Letter but told the newspaper he knew nothing about the findings until several months after the inspection. “I gotta be a little mad at FDA,” he said. “Had we been notified that they had done an inspection of Genetech and found these deviations, we would have stopped buying from them immediately.”

The *Post* says that so far Liveyon has not received an FDA Warning Letter, even though under federal regulations distributors are responsible for the safety of the products they distribute. Agency officials declined to discuss the case with the newspaper. Gottlieb said FDA “continues to investigate the circumstances surrounding the product, how it became contaminated, and how patients became injured, and may take additional action.”

Meanwhile, Liveyon officials say they now have their own laboratory and won’t rely on outside manufacturers. The company says it is planning a rapid expansion and wants to be selling in 13 countries by the end of this year. “The future for Liveyon is the brightest it’s ever been,” said founder and CEO **John Kosolcharoen**.