Twelve Week Clinical Outcome:
AmnioGenic Therapy™ and Chronic Wound Management
19 of 21 patients demonstrated 100% Margin Closure
100% of wound etiologies improved
During a twelve-week data collection period on stalled wounds, 100% of the AmnioGenic Therapy™ treated wounds improved (n=21); with no exclusion criteria, 100% of all etiologies improved with an associated 94.12% reduction in wound surface area. The wounds in this data collection had a mean non-healing duration of 36.76 (SD 30.66) weeks and mean baseline area of 10.49 cm2 (SD 19.02). Nineteen of twenty-one patients (90.4%) demonstrated 100% closure within twelve (12) weeks of initial procedure. In at least two cases, AmnioGenic Therapy ™ may have played a key role in addressing aggressive sinus tract/tunneling (ST/T) and subsequently preventing amputation by facilitating closure on a 24-month old and a 4-month old persistent diabetic ulcer.
Purpose / Scope:
The purpose of this twelve (12) month retrospective clinical observation was to gather information regarding the clinical performance of AmnioGenic Therapy ™, a cryopreserved structural tissue matrix derived from amniotic membrane and fluid that has been developed for clinical use to fill soft tissue defects, manage localized inflammation, or to address difficult-to-heal wounds. These patients were not selected; they represent the first twenty (n=21) chronic wounds treated with AmnioGenic Therapy ™ at five medical centers that completed the twelve (12) week post-procedure follow-up.
Metrics Patient Age (years) Non-healing (weeks) Time to Heal (weeks) Total Procedures Wound Start (cm2) Wound @ 12 weeks % Wound Decrease (cm2) % Wound Decrease (cm3) Mean (Arithmetic) 63.05 36.6 10.5 1.9 10.152 2.47 0.935 0.977 Standard Deviation 12.64 31.58 12.1 1.37 19.542 10.588 0.159 0.057 Confidence 5.54 13.84 5.3 0.6 8.56 4.64 0.07 0.03 MOE=5% 93.50% 97.71%
At twelve weeks post-procedure, nineteen of twenty-one AmnioGenic Therapy ™ treated chronic wounds demonstrated 100% closure. For all wound etiologies, 100% of wounds improved. AmnioGenic Therapy ™ appears to represent a novel, cost-effective, therapeutically effective, amnion-derived allograft of viable cells for chronic wound management, in vivo wounds and localized inflammation.
All wounds presented are difficult non-healing ulcers on which traditional wound care therapy had been exhausted. All patients involved in the data collection are severely immunocompromised, high-risk surgical candidates with complicated non-healing wounds and associated multiple co-morbidities, including:
- IMMUNOSUPPRESSIVE DRUGS POST ORGAN TRANSPLANT
- DEMONSTRATED RENAL INSUFFICIENCY
- SEVERE LYMPHODEMA
- VASCULAR INSUFFICIENCY
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