Air-Dried Human Amniotic Membrane Terminally Sterilized by Gamma Irradiation for Multidisciplinary Clinical Application

Detailed Description

Human amniotic membrane (hAM) is widely utilized in regenerative medicine due to its anti-inflammatory, anti-fibrotic, antimicrobial, and proepithelialization properties. It serves as a natural extracellular matrix scaffold enriched with growth factors and bioactive molecules that promote tissue repair and modulate the healing process. Ensuring sterility while preserving structural integrity and biological activity is essential for safe and effective clinical application.

Gamma irradiation is a well-established terminal sterilization method capable of achieving a high sterility assurance level. However, different irradiation doses may influence the mechanical strength, ultrastructural integrity, and biological properties of the membrane. Therefore, this prospective randomized interventional clinical study is designed to evaluate the safety and therapeutic effectiveness of air-dried human amniotic membrane sterilized at three different gamma irradiation doses: 15 kGy, 20 kGy, and 25 kGy.

The study includes two independent clinical cohorts conducted under a unified protocol:

• Diabetic Foot Ulcer (DFU) Cohort

Participants with chronic diabetic foot ulcers will be randomly assigned to receive air-dried hAM sterilized at 15 kGy, 20 kGy, or 25 kGy. The membrane will be applied as a biological wound dressing in addition to standard wound care. Clinical evaluation will include rate of complete wound closure, percentage reduction in wound area, time to full epithelialization, infection rate, pain reduction, and overall quality of tissue regeneration.

Comparative analysis will be performed to assess potential dose-response effects across both cohorts. The primary objective of the study is to determine the optimal gamma irradiation dose that ensures effective sterilization while preserving the biological functionality and regenerative capacity of the membrane.

The findings are expected to support the development of a safe, ready-to-use, room-temperature stable biological graft suitable for multidisciplinary clinical applications, particularly in chronic wound management and ocular surface reconstructs.

Inclusion criteria

• 1. Patients requiring ocular surface reconstruction due to chemical/thermal burns, persistent epithelial defects, or conjunctival defects.

• Patients with chronic non-healing diabetic foot ulcers (DFU) of at least 4 weeks duration.

• Ability to understand the study procedures and provide written informed consent.

• For tissue donors (placenta): healthy mothers undergoing elective cesarean delivery with negative infectious disease screening (HIV, HBV, HCV, syphilis).

Exclusion criteria

• Active systemic infection or sepsis.
• Immunocompromised patients (HIV positive, ongoing immunosuppressive therapy).
• Pregnant or breastfeeding women.
• History of malignancy in the past 5 years.
• Known allergy or hypersensitivity to human amniotic tissue or materials used in graft preparation.
• Participation in another investigational clinical trial within 30 days prior to enrollment

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