A Grand Bahama-based medical facility yesterday unveiled a new treatment for patients with diffuse scleroderma.

The Okyanos Center for Regenerative Medicine announced it is offering a new and advanced protocol, based on the STAR clinical trial, which could aid more than 50,000 Americans afflicted by the illness.

Cytori Therapeutics reported the findings of the STAR trial earlier this year. The procedure used adipose derived regenerative cells (ADRCs) to treat scleroderma affecting the hands and fingers.

The trial evaluated 88 participants, 51 of whom had diffuse scleroderma, a more severe form of the disease. At the end of the study, those patients treated for diffuse cutaneous scleroderma showed significant improvements in hand function and functional disability scores 48 weeks after treatment.

Okyanos said more than 50,000 Americans suffer with diffuse scleroderma, the most severe type of this autoimmune disease. This treatment, which is currently not being offered in the US, will now be made available at its Grand Bahama facility.

"Through the delivery of regenerative therapies, our mission at Okyanos is to restore and extend healthy living," said Vincent Burton, Okyanos's president.

"We are offering this advanced protocol as an opportunity for symptomatic relief for patients with skin manifestations of diffuse scleroderma, as well as to allow treating physicians to consider an additional option to help their patients feel better."

"ADRCs are an active stem cell population. The evidence of clinical benefit in the STAR trial parallels the effects we see in patients with multiple chronic conditions who we treat with ADRCs," said Dr Marc Penn, Okyanos's director of research and development.

"Our new protocol for diffuse cutaneous scleroderma is another significant example of Okyanos' commitment to expanding our offering of evidence-based regenerative medicine treatments."

As an autoimmune disease, scleroderma damages connective tissue and can be difficult to diagnose. One of its most serious conditions is systemic scleroderma, where the 'sclerosis' or hardening of the tissue often occurs in the internal systems of the body, such as the lungs, kidneys, heart and gastrointestinal organs. The two categories of systemic scleroderma are limited and diffuse, with the latter being more severe.

Those patients enrolled in the STAR trial with diffuse scleroderma showed improvements in the Cochin Hand Function Score and the Health Assessment Questionnaire-Disability Index (HAQ-DI), a measure of functional disability.This met or exceeded the published criteria for minimally important clinical differences in these measures (6.5 points for Cochin1, 0.22 points for HAQ-DI2).

The protocol used by Okyanos involves patients undergoing fat harvest through small volume liposuction under anesthesia. The extracted lipoaspirate is then processed to produce ADRCs for same-day administration into all fingers of both hands. In addition, the patient will receive an intravenous infusion of ADRCs.