Okyanos is proud to bring hope to the more than 50,000 Americans suffering on a daily basis with diffuse scleroderma, the most severe type of this devastating autoimmune disease. The advanced stem cell therapy protocol available at Okyanos, 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.
Scleroderma (also called systemic sclerosis) is a devastating autoimmune rheumatic disease which damages connective tissue. One of the most serious classifications of this disease is known as diffuse scleroderma wherein the “sclerosis” (hardening of the tissue) occurs in the internal systems of the body, causing damage and widespread scarring to the skin as well as to various internal organs such as the lungs, kidneys, heart and gastrointestinal organs.
Diffuse scleroderma is characterized by a lower survival rate than other forms of the disease, and no curative pharmacological treatment options have been developed to-date. The disease process of diffuse scleroderma involves a number of different factors, including:
- Abnormal immune system responses
- Damage to vascular system
- Chronic inflammation
Fat: An Abundant Source of Stem Cells
Adipose-derived regenerative cells (ADRCs) are understood to promote repair and healing in both scarred and injured tissue. At Okyanos, ADRCs are obtained from patients’ own fat tissue for use in treatment. While there are many precise mechanisms of ADRCs that continue to be investigated, there is robust scientific evidence that they have the capacity to address inflammation, stimulate new blood vessel formation, prevent premature cell death and secrete substances that encourage repair and regeneration.
Adult Stem Cell Treatment for Scleroderma
Using 19 leading medical centers in the United States, the double-blind, randomized, placebo-controlled STAR trial enrolled and evaluated 88 participants, 51 of whom had diffuse scleroderma. 48 weeks after treatment, those patients treated for diffuse cutaneous scleroderma showed significant improvements in:
- Hand function (as measured by Cochin hand score)
- Functional ability (as measured by Health Assessment Questionnaire-Disability Index or HAQ-DI)
Patients who received this protocol also saw slight improvements in their Raynaud’s Condition Score. Importantly, trial investigators saw no significant safety issues related to the procedure itself.
Okyanos is proud to offer patients suffering with this difficult disease a new and advanced treatment option that is not currently available in a clinical setting anywhere in the United States.
How Treatment Works
At Okyanos, the advanced stem cell therapy protocol for diffuse scleroderma involves three basic steps:
- First a small-volume, water-assisted liposuction is performed for the purpose of fat harvesting.
- The tissue is then processed to produce ADRCs for administration.
- Regenerative cells are then delivered directly into all fingers of both hands, as well as systemically by intravenous infusion.
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 are followed post-treatment and efficacy data is obtained by a third-party contract research organization.