A new treatment using adipose-derived regenerative cells (ADRCs) to treat hand problems caused by scleroderma is now available at Okyanos Center for Regenerative Medicine in Freeport, Grand Bahama. Researchers developed the treatment protocol based on the STAR clinical study sponsored by Cytori Therapeutics.
“Through the delivery of regenerative therapies, our mission at Okyanos is to restore and extend healthy living,” Vincent Burton, MBBS, FRCA, president at Okyanos, said in a press release. “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.”
The STAR clinical trial (NCT02396238) tested the therapeutic potential of ADRCs to treat hand and finger dysfunction caused by scleroderma-associated constriction of blood vessels and reduced blood flow. The trial was conducted in 19 medical centers across the United States with 88 scleroderma patients who had hand problems and Raynaud’s phenomenon. Fifty-one of these patients had the diffuse form of the disease.
Patients received two injections of ADRCs or a placebo in each finger and were followed for 48 weeks. Overall, the treatment was found to lack therapeutic potential to reduce hand dysfunction. However, in the subgroup of patients with diffuse scleroderma, the treatments showed promise. Patients with diffuse scleroderma who received the treatment showed two times higher hand function scores compared with those who received a placebo.
“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, director of research and development at Okyanos. “Our new protocol for diffuse cutaneous scleroderma is another significant example of Okyanos’ commitment to expanding our offering of evidence-based regenerative medicine treatments.”
The protocol used by Okyanos requires the collection of fat tissue from patients that is then processed to isolate ADRCs. The stem cells are administrated on the same day into all fingers of both hands via subcutaneous injection. Additionally, each patient receives an intravenous infusion of the stem cells.
The safety of ADRCs has been well-established in the field of regenerative medicine, demonstrating no toxicity in several patient groups. All patients treated at Okyanos are carefully followed-up after treatment by a third party researcher to study the therapy’s effectiveness.