Okyanos Center for Regenerative Medicine Announces New Treatment Option for Diffuse Scleroderma Based on STAR Trial Protocol

Okyanos Center for Regenerative Medicine's New Treatment Option for Diffuse Scleroderma

Freeport, Grand Bahama (October 4, 2017) – Okyanos Center for Regenerative Medicine today announced that Okyanos is now offering a new and advanced protocol for diffuse scleroderma based on the well-established protocol implemented in the STAR clinical trial.

Earlier this year Cytori Therapeutics, Inc., reported the findings of the STAR trial which used adipose derived regenerative cells (ADRCs) to treat scleroderma affecting the hands and fingers. Using 19 leading medical centers in the United States, the double-blind, randomized, placebo-controlled trial enrolled and 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’ new treatment protocol brings hope to the more than 50,000 Americans suffering on a daily basis with diffuse scleroderma, the most severe type of this autoimmune disease. This protocol, which is currently not being offered in the United States, is an important therapeutic option for the skin manifestations of this type of systemic scleroderma and is now being offered at the Okyanos Center for Regenerative Medicine in Freeport, Grand Bahama.

“Through the delivery of regenerative therapies, our mission at Okyanos is to restore and extend healthy living,” said Vincent Burton, MBBS, FRCA and President at Okyanos. “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 Marc Penn, MD, PhD, FACC and Director of Research & Development at Okyanos. “Our new protocol for diffuse cutaneous scleroderma is another significant example in 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 the most serious classifications of scleroderma is systemic scleroderma where the “sclerosis” or hardening of the tissue often occurs in the internal systems of the body, involving the skin in addition to various internal organs 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.

At the end of the study, 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 and an important secondary endpoint, which 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. This lipoaspirate is then processed to produce ADRCs for same-day subcutaneous administration into all fingers of both hands. In addition the patient will receive an intravenous infusion of ADRCs. The safety profile for ADRCs is well-established in regenerative medicine with no toxicity in thousands of patient data sets. All patients treated at Okyanos who consent, including those treated for diffuse scleroderma, are followed post-treatment and efficacy data is obtained by a third-party contract research organization.

To learn more about this advanced treatment option for diffuse scleroderma and to explore candidacy, click here.

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Combining state-of-the art technologies delivered in a cell therapy center of excellence, Okyanos Center for Regenerative Medicine is a leading adult stem cell therapy provider located in Freeport, Grand Bahama. Okyanos was founded in 2011 and is licensed and accredited by the Bahamas’ National Stem Cell Ethics Committee (NSCEC) under the Bahamas Stem Cell Therapy and Research Act to provide cell therapy to patients with chronic medical needs that, per scientific research, clinical trials and application, can be safely and potentially efficaciously treated with patients’ own adipose-derived stem and regenerative cells. The literary name Okyanos, the Greek god of the river Okeanos, symbolizes restoration of blood flow. Learn more at http://www.okyanos.com.