American Medical Association Adding Cytori’s Cell-Based Therapy for Scleroderma Hand Problems to Key Database

The American Medical Association is adding descriptions of Cytori Therapeutics’ cell-based therapy for scleroderma of the hands to its authoritative database of medical procedures, services and technology.

Because so many players in the American healthcare system use the database as a reference, the addition of the descriptions will help Cytori spread the word in the medical community about the Habeo Cell Therapy it is developing. The company said the descriptions will also help it continue to advance the therapy through the clinical trial process.

A code accompanies each of the descriptions in the AMA’s Current Procedural Terminology database. The code-based descriptions provide information about medical procedures and services to doctors, patients, government healthcare agencies, medical accreditation associations, health insurance companies and others.

The AMA’s Current Procedural Terminology Editorial Panel approved Cytori’s request to add the descriptions to the database’s Category III listings, which cover emerging healthcare technology, procedures and services. The AMA has published the two codes and the descriptions that they cover on its website. They will become effective on Jan. 1, 2018.

Cytori worked with the American College of Rheumatology, the American Society of Plastic Surgeons, and the American Society for Surgery of the Hand on its application request to the AMA.

“We applaud the Editorial Panel’s approval of these two new CPT [Current Procedural Terminology] codes, as it marks the essential first step in enabling physician and facility access to our investigational Habeo Cell Therapy in the U.S.,” Russ Havranek, a Cytori vice president, said in a press release. “We are also thankful for the support provided by the medical specialty societies in helping us achieve this important milestone.”

With Habeo Cell Therapy, treatments are derived from specialized cells in patients’ own tissue that play a role in healing processes. They include stem, lymphatic, immune, and mesenchymal and endothelial progenitor cells.

Cytori is evaluating Habeo Cell Therapy as a treatment for scleroderma-related hand dysfunction in the U.S.-based Phase 3 STAR clinical trial (NCT02396238). A previous trial in France, SCLERADEC-I (NCT01813279), showed that the therapy could reverse scleroderma’s effect on patients’ hands over the long term.

The new AMA codes that will cover Habeo Cell Therapy are:

• 0489T – for autologous adipose-derived regenerative cell (ADRC) therapy to treat scleroderma in the hands, which includes the process of adipose tissue harvesting, isolation and preparation of regenerative cells.
• 0490T – for autologous ADRC therapy to treat scleroderma in the hands, which includes the administration process by multiple injections in one or both hands.

“The codes approved by the panel accurately describe Habeo Cell Therapy,” said Dr. Mark Granick, chief of plastic surgery at Rutgers New Jersey Medical School.

“The use of ADRCs for treating scleroderma-related hand dysfunction requires far more specificity and effort than the more commonly performed liposuction or fat grafting procedures,” he said. “The injection of the ADRC solution into the fingers similarly is a highly specialized process requiring a familiarity with hand anatomy and surgery.”

“Scleroderma with hand dysfunction is an extremely debilitating disease, and yet patients historically have had very limited treatment options,” said Dr. Dinesh Khanna, director of the University of Michigan Medical School’s scleroderma program and principal investigator of the STAR trial. “Habeo Cell Therapy is a novel treatment with the potential to make a significant impact in these patients’ lives. I am encouraged by the clinical evidence generated to date and look forward to reviewing the STAR 48-week results.”