Positive Results From Wound Healing Tests Of Regenerative Cell Technology.
HOUSTON, Texas, September 18, 2017 -- Investigator-initiated testing of InGeneron's adipose-derived regenerative cell (ADRC) technology in chronic venous leg ulcers and mixed arterial venous ulcers was reported recently.
The ulcers treated are the most common types of chronic leg wounds in the Western world, especially among elderly patients.
Both conditions are associated with severe pain impairing quality of life and complex as well as time-consuming treatment regimes.
The case series was conducted in collaboration with the Department of Dermatology at the University Hospital rechts der Isar Munich.
Chronic leg wounds are associated with a complicated disease progression and severe pain, impairing quality of life.
Current treatment options are complex, time consuming and require high medical expenses.
New therapeutic interventions that improve outcomes in these patients could have an important therapeutic impact.
"The results that we have achieved in this case series are remarkable because we have been able to restore wound healing capabilities and decrease pain in multimorbid patients with large venous and mixed arterial-venous ulcers with a one time minimally invasive application, while demonstrating a very good safety and tolerability profile," said Alexander Konstantinow, primary investigator of the study. "InGeneron's point of care system has the potential to benefit many patients with wound healing disorders of vascular origin, while being more cost effective compared to available standards of care."
The case series comprised 16 multimorbid leg ulcer patients (12 male, 4 female) ranging in age from 52 to 84 years who were treated with autologous ADRCs prepared at point of care with InGeneron's Transpose RT system.
Seven patients were presenting with venous leg ulcers, nine with mixed arterial-venous ulcers.
Within 10 to 25 weeks, 11 out of the 16 patients showed complete wound closure. All seven venous leg ulcers patients showed complete epithelialization.
Moreover, the group of venous ulcer patients reported significant pain decrease by more than 90 percent 14 days post treatment.
After nine to 44 months of follow up across all patients, no severe side effects were observed, demonstrating good overall safety and tolerability of the therapy in this patient population.
InGeneron plans to initiate a FDA feasibility study in the U.S. soon.
The prospective, randomized, single-site study will investigate the safety and tolerability of InGeneron's point of -care regenerative cell therapy in venous leg ulcer patients.
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|Title Annotation:||In The Clinic|
|Publication:||Stem Cell Research News|
|Date:||Oct 9, 2017|
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