According to the Public Relations, this report examines the scientific reasons for these contraindications, international requirements, their role in quality assurance, and also the risks that arise for recipients of samples if these conditions are ignored.
What are contraindications for contracts? Contraindications for contracts refer to conditions in which a cord blood sample is not suitable for storage due to scientific or medical reasons. The identification of these conditions is based on health questionnaires, specialized test results, review of family history, and sample evaluation. If these conditions exist, the bank is unable to enter into a contract.
Scientific and Medical Reasons for Contraindications Contraindications for cord blood storage are usually applied for one of the following reasons:
-
Genetic or Congenital Disorders Examples of related diseases: Thalassemia major, Fanconi anemia, Down syndrome Reason for contraindication: Possibility of disease transmission to the recipient or ineffectiveness of future treatment.
-
Presence of Dangerous Infections in the Mother Common viruses and agents: HIV, Hepatitis B and C, Syphilis, HTLV-I/II Reason for contraindication: Sample contamination and possibility of disease transmission in stem cell transplantation.
-
Blood or Cancer Disorders in the Family Examples: Family history of leukemia, primary immunodeficiency, bone marrow disorders Reason for contraindication: High genetic risk and possibility of the child being a carrier.
-
Insufficient Sample Volume or Quality Examples: Cord blood volume below 30 ml or MNC count lower than 6x10⁸ Reason for contraindication: Low efficacy in future treatments.
Royan's Adherence to Global Standards Royan Cord Blood Bank is always committed to adhering to the guidelines of the AABB and other reputable international bodies. These contraindications are not solely based on internal decisions but are fully consistent with the following requirements:
Most important AABB requirements for contract contraindication: Rejection of samples if a transmissible infectious or genetic disease is identified. Necessity to check volume and cell count before storage. Performing maternal health tests during pregnancy and after delivery. Obtaining informed consent forms that include a full explanation of contract rejection criteria.
What are the risks if contraindications are not observed? Storing samples that should be subject to contraindications can have irreparable consequences:
Potential Risks: Infection Transmission: Especially in cases like HIV or Hepatitis. Transplant Inefficiency: Due to insufficient cell count or genetic defects in the sample. Futility of Costs: High cost of transplantation for ineffective or contaminated samples. Psychological Harm: For the recipient's family in case of treatment failure. In fact, not adhering to these standards undermines public trust in the biobank system.
Why is observing contraindications an ethical and scientific principle? Adherence to contract contraindications is not only a scientific requirement but also an ethical commitment. Storing a low-quality sample for financial gain can endanger a patient's life in the future. Therefore, banks that do not comply with reputable standards such as AABB, FACT, or NetCord will not only be scientifically disqualified but also ethically responsible for harmful consequences.
Alignment with Global Cord Blood Banks In this regard, reputable global banks such as DKMS in Germany, Be The Match in the United States, and Anthony Nolan in the United Kingdom also follow similar frameworks. For example, if the number of CD34+ cells in a sample is less than a specified amount or if the mother's viral tests are positive, these samples are not stored, and parents are informed that the process has been stopped. If the mother is a carrier of the hepatitis virus and PCR test results are positive, the sample is completely rejected. These criteria are essential to ensure the effectiveness and safety of samples in therapeutic applications.
NetCord-FACT standards for cord blood banks, developed by FACT, explicitly require that samples with low volume or insufficient stem cell count (especially CD34⁺) should not be stored. Additionally, maternal viral tests (HIV, Hepatitis B/C, Syphilis, etc.) are mandatory; if there is a positive result, the storage process is stopped.
The WMDA (World Marrow Donor Association) also states in its standards for cord blood banks that the mother must undergo infection tests such as HIV, HTLV-I/II, hepatitis, syphilis, etc., within 7 days before or after delivery, and any positive result leads to sample rejection.
In banks like DKMS Germany, a NetCord-FACT member, protocols include checking volume, cell quality, and viral test validity to ensure the effectiveness and safety of the sample at an international level.
Also, in the NMDP/Be The Match guidelines in the US, there are limitations for the minimum number of cells (TNC and CD34⁺); for example, a minimum TNC = 1.5x10⁷/kg and CD34⁺ ≥ 1x10⁵/kg per unit. Below these thresholds, the sample is not considered suitable for transplantation and is not stored.
Consequently, the information mentioned in the report from reputable banks is directly derived from these international standards (NetCord-FACT, WMDA, NMDP) and not merely based on general statements or assumptions.
Conclusion Royan Cord Blood Bank, by strictly observing the contraindications for contracts, not only ensures the health of the samples but also, by emulating the most reputable international bodies such as AABB, has implemented global standards in its services.
In contrast, organizations that proceed with storage without considering these contraindications will face increased risks of disease transmission, transplant failure, and reduced therapeutic efficacy. This not only endangers the health of patients but also undermines public trust in the healthcare system and biobanks. End of content/