What Is an Allograft?

The National Cancer Institute defines an allograft as the transplantation of organs, tissues, or cells from one individual of a species to another genetically non-identical individual of the same species. Linguistically, the term combines “allo” (meaning “other” or “same species”) and “graft” (meaning “to implant” or “transplant”).

The American Association of Tissue Banks (AATB) classifies allografts into two categories based on their donors: living or deceased.
In essence, an allograft refers to tissues harvested from a deceased or living donor for transplantation into a recipient. The process of delivering allograft products can be divided into two main phases: tissue procurement and tissue processing.

Tissue Procurement:

This involves donor consent, social work, evaluating medical and clinical histories, and harvesting tissues. In Iran, these activities are currently conducted by medical universities, the Legal Medicine Organization, and under the supervision of the Ministry of Health.

Tissue Processing:

After reviewing donor documentation and ensuring the quality of raw tissues, processing units produce allograft products. These products undergo strict quality checks before being distributed.

Allograft vs. Autograft: Which Is Better?

Both allografts and autografts have unique advantages and limitations. The choice depends on the patient’s condition and the physician’s recommendation.

Autografts, where tissues from one part of a patient’s body are transplanted to another part, are considered the gold standard due to their compatibility. However, issues like limited tissue availability, additional surgical sites, and increased pain make alternatives, such as allografts, xenografts (from animals), and synthetic grafts, essential.

Given these limitations, allografts are now recognized as the best alternative for tissue replacement.

Types of Allografts Based on Anatomical Source

Allografts can be categorized by tissue type and anatomical origin:

Types of Allografts Based on Processing

The processing methods of allografts depend on the manufacturing technology. Regen products by Iranian Tissue Product Co. (ITP Co.) are classified as follows:

 

Lyophilized (Freeze-Dried) Allografts

    • Treated with gamma radiation. Stored at room temperature.

Alcohol-Immersed Allografts

    • Treated with gamma radiation. Stored in refrigerators (0–4°C).

Cryopreserved Allografts

    • Processed aseptically. Stored at -40°C to -180°C.

Glycerol-Immersed Allografts

    • Treated with gamma radiation. Stored in refrigerators (0–4°C).

Do Allografts Carry the Risk of Disease Transmission?

The risk of viral or infectious disease transmission through allografts is extremely low due to rigorous safety measures. Key considerations include:

Donor Screening:

    • Comprehensive clinical history evaluations.
    • Pathobiological testing for infectious diseases according to international standards.
    • Multiple tests are conducted to eliminate errors, ensuring that tissues from infected donors are not used.

Processing Protocols:

    • Antibiotic, enzymatic, and chemical treatments.
    • Advanced techniques from tissue engineering and molecular biology.
    • These procedures significantly reduce the likelihood of viral remnants.

Gamma Sterilization:

    • Products are sterilized using 25 kGy gamma radiation by the Atomic Energy Organization, ensuring sterility and eliminating the risk of disease transmission.

In conclusion, the risk of infectious disease transmission via allografts is nearly zero.

Quality Assurance and Control

ITP Co. adheres to global standards to ensure product safety and efficacy:

    • Donor Selection: Compliance with AATB and WHO guidelines.
    • Government Compliance: Operations aligned with the Iranian Ministry of Health regulations.
    • Certifications: ISO 13485:2016 certification from KGS.
    • GMP Compliance: Production in clean rooms monitored by the Iranian Medical Devices Administration.
    • FDA Standards: Alignment with the Iranian FDA.
    • Gamma Sterilization: Products sterilized by the Atomic Energy Organization.

This meticulous process guarantees the safety and effectiveness of allograft products, meeting both local and international standards.