Pilot Study: Human Adipose Tissue Allograft for Fat Pad Defects in Patients With Preulcerative Lesions

Area of Science:

• Biomedical Engineering
• Regenerative Medicine
• Podiatric Medicine

Background:

• Plantar fat pad loss increases pressure, causing painful ulcers, especially in diabetic neuropathy patients.
• High recurrence rates of diabetic foot ulcers often lead to amputations.
• Restoring the plantar fat pad is an unmet clinical need, as current treatments focus on pressure reduction.

Purpose of the Study:

• To evaluate the safety and potential efficacy of human cryopreserved adipose tissue (hCAT) allografts for repairing plantar fat pad defects.
• To assess hCAT's performance in preventing plantar ulcerations in patients with diabetic neuropathy.

Main Methods:

• hCAT was scientifically characterized for structural properties, immunogenicity, persistence, and remodeling in vitro and in vivo.
• A retrospective analysis of 12 diabetic neuropathy patients with preulcerative lesions receiving hCAT implants was conducted.
• Adverse events and ulcer recurrence rates were analyzed post-implantation.

Main Results:

• hCAT implants remained palpable and no ulcerations occurred in patients for an average of 6.4 months.
• No product-related adverse events were reported.
• Long-term follow-up of implanted patients is ongoing.

Conclusions:

• hCAT allografts appear safe and potentially beneficial for managing patients at risk of plantar ulcerations.
• Further research is necessary to fully evaluate hCAT's potential in preventing high-risk plantar ulcer formation.