Cord blood accreditation: Accreditation Standards for Cord Blood Collection and Storage

1. Introduction to Cord Blood Banking

cord blood banking represents a significant advancement in medical science, offering a source of hematopoietic stem cells that could potentially treat a variety of diseases. Unlike traditional bone marrow transplants, cord blood does not require a perfect match between donor and recipient, which makes it an invaluable resource for patients with rare tissue types or those who are unable to find a match within their family or bone marrow donor registries. The process involves collecting blood left in a newborn's umbilical cord and placenta, which is then cryopreserved for future medical use. This practice has gained momentum due to its role in treating blood disorders, immune deficiencies, and certain cancers.

From the perspective of expectant parents, cord blood banking offers a form of biological insurance, providing peace of mind that they have access to potentially life-saving treatment options for their child or close family members. Medical professionals view cord blood as a less invasive and more readily available alternative to bone marrow, with the added benefit of lower rejection rates in transplants. Ethically, it raises questions about the commercialization of human tissues and the responsibilities of cord blood banks in maintaining the viability and purity of the samples.

Here is an in-depth look at the key aspects of cord blood banking:

1. Collection Process: The collection of cord blood is safe, painless, and does not interfere with the delivery process. It must be done within minutes after birth, ensuring that the blood is still rich in stem cells. For example, a sterile needle is used to draw blood from the cord once it has been clamped and cut.

2. Testing and Processing: After collection, the cord blood undergoes rigorous testing for infectious diseases and contamination. It is then processed to concentrate the stem cells and remove any debris or red blood cells that are not needed for transplantation.

3. Cryopreservation: The processed cord blood is slowly cooled to a sub-zero temperature to preserve the stem cells' viability over the long term. An example of this is the use of controlled-rate freezers that gradually bring the temperature down to prevent ice crystal formation, which can damage the cells.

4. Accreditation Standards: Accreditation bodies, such as the AABB (formerly known as the American Association of Blood Banks) and FACT (Foundation for the Accreditation of Cellular Therapy), set rigorous standards for cord blood collection, processing, and storage to ensure the highest quality and safety.

5. Potential Uses: Cord blood stem cells are currently used in the treatment of over 80 diseases, including leukemia, lymphoma, and sickle cell anemia. For instance, a child with sickle cell disease may receive a cord blood transplant to replenish their body with healthy blood-forming cells.

6. Ethical Considerations: The decision to bank cord blood should be made after careful consideration of the ethical implications, such as the potential for private banks to exploit parental fears or the debate over public versus private banking.

7. Costs and Insurance: Private cord blood banking can be expensive, with initial fees and annual storage costs. Some insurance plans may cover these expenses if cord blood is being banked for a sibling with a known medical condition that can be treated with stem cells.

8. Public Donation: Families may also choose to donate their baby's cord blood to a public bank, where it can be made available to anyone in need of a transplant. This altruistic option has the added benefit of increasing the diversity of the cord blood available, which is crucial for patients from underrepresented ethnic groups.

Cord blood banking is a complex but promising field that balances medical innovation with ethical responsibility. It offers hope for many patients and challenges us to consider the value and potential of what was once considered medical waste.

2. Importance and Benefits

Accreditation in the context of cord blood banking is a critical process that ensures the quality and safety of cord blood collection, processing, and storage. It serves as a benchmark for facilities to adhere to the highest standards of practice. This process is not only a means to validate the credibility of a cord blood bank but also acts as a guide for continuous improvement. From the perspective of healthcare providers, accreditation is a reassurance of excellence in service and patient care. For patients and their families, it is a symbol of trust and reliability in the preservation of their valuable cord blood samples. Moreover, regulatory bodies rely on accreditation to enforce compliance with medical and ethical standards.

From different points of view, the importance and benefits of accreditation can be summarized as follows:

1. Quality Assurance: Accreditation provides a structured framework for cord blood banks to maintain high-quality standards. For example, the AABB (formerly known as the American Association of Blood Banks) requires accredited institutions to undergo rigorous peer-reviewed assessments to ensure they meet or exceed established standards.

2. Public Trust: When a cord blood bank is accredited, it instills confidence in the public that the facility is committed to safeguarding their health interests. An example of this is the Family cord Blood Services' accreditation by the AABB, which assures families of the quality of their cord blood banking services.

3. Regulatory Compliance: accredited cord blood banks are often better equipped to comply with local and international regulations. This is crucial in a field where guidelines are constantly evolving to reflect new scientific knowledge and ethical considerations.

4. Operational Efficiency: Through the process of accreditation, cord blood banks can streamline their operations, leading to increased efficiency and potentially lower costs. This was evident when Cryo-Cell International improved its processing times after receiving accreditation.

5. Clinical Outcomes: Accreditation can directly impact clinical outcomes by ensuring that cord blood units are collected, processed, and stored in a way that preserves their therapeutic quality. A study published in the New England Journal of Medicine showed that patients receiving transplants from accredited facilities had better survival rates.

6. Research and Development: Accredited facilities are often at the forefront of research due to their adherence to high standards. This commitment to excellence drives innovation, as seen in the groundbreaking work on stem cell expansion technologies at accredited institutions.

7. Global Recognition: Accreditation can open doors to international collaboration and recognition. For instance, the NetCord-FACT accreditation is recognized worldwide and allows for the global exchange of cord blood units.

8. Insurance and Reimbursement: Insurance companies may preferentially cover services provided by accredited cord blood banks, recognizing the added value of accreditation in terms of quality and safety.

9. Educational Advancement: Accreditation often requires that staff undergo continuous education, which leads to a more knowledgeable workforce capable of providing better care and advancing the field.

10. Market Differentiation: In a competitive industry, accreditation can distinguish a cord blood bank from its competitors, signaling a commitment to excellence that can attract more clients.

Accreditation is a multifaceted process that brings numerous benefits to all stakeholders involved in cord blood banking. It is a dynamic and ongoing commitment to quality, safety, and excellence that ultimately serves the best interests of patients and the broader healthcare community. The importance of accreditation cannot be overstated, as it is a key factor in the advancement of cord blood therapies and the growth of the regenerative medicine field.

3. Key Accreditation Bodies and Their Roles

Accreditation plays a pivotal role in ensuring the quality and safety of cord blood collection and storage. It is a process through which organizations are evaluated against established standards to ensure they meet the high levels of quality necessary for medical procedures. This process is overseen by key accreditation bodies, each with its own set of standards and protocols. These bodies not only set the benchmarks for best practices but also regularly review accredited facilities to ensure ongoing compliance. Their role is crucial in instilling confidence among patients, healthcare providers, and regulatory agencies that the cord blood bank is competent and capable of handling the complex processes involved in cord blood collection, processing, and storage.

From the perspective of a patient or donor, these accreditation bodies are guardians of safety and efficacy. They want assurance that the cord blood bank handling their donation adheres to the highest standards. For healthcare providers, accreditation is a signifier of trust and reliability in the cord blood's viability for transplantation. Regulatory agencies look to these bodies to uphold industry standards and protect public health interests. Meanwhile, from the viewpoint of the cord blood banks themselves, achieving and maintaining accreditation is essential for operational excellence and competitive advantage.

Here are some of the key accreditation bodies and their roles:

1. AABB (formerly known as the American Association of Blood Banks): This international body is known for its comprehensive standards for blood banks and transfusion services. It provides accreditation for cord blood facilities that meet its rigorous standards for donor management, collection, processing, testing, distribution, and administration.

- Example: A cord blood bank accredited by AABB must have detailed protocols for every step of the cord blood handling process, ensuring traceability and integrity of the cord blood units.

2. FACT (Foundation for the Accreditation of Cellular Therapy): FACT sets standards for both clinical and laboratory aspects of cellular therapies. Its accreditation is often considered the gold standard for facilities involved in stem cell therapy, including cord blood banks.

- Example: A FACT-accredited facility must demonstrate not only technical competence in processing cord blood but also excellence in clinical practices related to transplantation.

3. CAP (College of American Pathologists): While CAP is widely recognized for its laboratory accreditation program, it also provides guidelines and standards for the collection and storage of cord blood. CAP accreditation ensures that the laboratory testing of cord blood is performed to the highest standard.

- Example: CAP-accredited cord blood banks must adhere to strict quality control measures for laboratory testing to ensure the accuracy and reliability of results.

4. ISO (International Organization for Standardization): ISO certification is an internationally recognized standard that indicates a facility's adherence to quality management principles. For cord blood banks, an ISO certification means that the facility has a robust quality management system in place.

- Example: An ISO-certified cord blood bank must have systematic processes for continuous improvement and must ensure customer satisfaction.

5. NetCord-FACT: This is a collaborative effort between NetCord and FACT to establish international standards for cord blood collection, processing, testing, banking, selection, and release.

- Example: NetCord-FACT accreditation requires cord blood banks to have both a high level of medical and technical expertise and to follow international best practices for cord blood collection and use.

These accreditation bodies serve as the pillars of quality assurance in the field of cord blood banking. They provide a framework for facilities to deliver safe and effective cord blood units for transplantation, research, and other therapeutic applications. Their rigorous standards and regular audits ensure that cord blood banks operate at the forefront of medical and technological advancements, offering hope and life-saving treatments to patients worldwide.

4. Step by Step

The accreditation process for cord blood collection and storage is a meticulous and multi-faceted procedure that ensures the highest standards of quality and safety are met. It involves a series of steps designed to evaluate and verify that a cord blood bank's operations comply with international standards. This process is critical because it validates the bank's capabilities in preserving the integrity and viability of cord blood, which may one day be used in life-saving stem cell transplants. The process is not only a reflection of a bank's technical competence but also its commitment to ethical practices and continuous improvement.

From the perspective of a cord blood bank, the process begins with a thorough self-assessment, followed by a rigorous external audit. For expectant parents considering cord blood banking, the accreditation signifies trust and reliability in the service provided. Healthcare professionals look at accreditation as a benchmark for recommending cord blood banks to patients. Here's a detailed look at the steps involved:

1. Preparation and Self-Assessment: The cord blood bank conducts an internal review against the accreditation standards. This includes ensuring proper documentation, staff qualifications, and equipment calibration. For example, a bank might review its procedures for collecting cord blood to ensure they minimize contamination risk.

2. Application Submission: The bank submits an application to the accrediting body, along with supporting documents that demonstrate compliance with the standards.

3. Document Review: The accrediting body reviews the submitted documents to assess the bank's policies and procedures. Discrepancies or areas needing improvement are identified and communicated back to the bank.

4. On-Site Inspection: Accreditation assessors visit the cord blood bank to conduct an on-site inspection. They observe practices, interview staff, and review records to ensure that the bank's operations align with its documented procedures.

5. Corrective Actions: If any non-conformities are identified during the inspection, the bank must address these through corrective actions. For instance, if the temperature logs for storage units show inconsistencies, the bank must not only correct the immediate issue but also implement a long-term solution to prevent recurrence.

6. Accreditation Decision: After the on-site inspection and review of corrective actions, the accrediting body makes a decision on accreditation status. Successful banks receive accreditation, which is typically valid for a specific period before re-evaluation is required.

7. Continuous Improvement: Accredited cord blood banks are expected to engage in continuous improvement activities. This might involve regular staff training, updating equipment, or adopting new technologies that enhance cord blood collection and storage.

Throughout this process, the role of the accrediting body is to act as an impartial observer, ensuring that the bank meets the established criteria. The goal is to foster a culture of excellence that prioritizes the health and safety of donors and potential recipients. The accreditation process is not just a one-time event but an ongoing commitment to quality and excellence in the field of cord blood banking.

5. Best Practices

cord blood collection and storage is a meticulous process that demands adherence to stringent standards to ensure the viability and safety of the cord blood units for future therapeutic use. The best practices in this field are informed by a combination of clinical experience, scientific research, and regulatory compliance. These practices are designed to maximize the quantity and quality of the stem cells collected, which are critical for successful transplantation and treatment outcomes. They also aim to protect the health and safety of both the donor and the recipient.

From the perspective of healthcare providers, the priority is to collect cord blood without compromising the well-being of the mother or the newborn. This involves training medical staff in efficient collection techniques that must be performed immediately after birth. On the other hand, regulatory bodies focus on establishing criteria that cord blood banks must meet to be accredited, which includes proper documentation, testing for infectious diseases, and ensuring the sterility of the collected sample.

Here are some in-depth best practices for cord blood collection:

1. Pre-Collection Counseling and Consent: It is essential to obtain informed consent from the expectant parents well before the onset of labor. This includes providing them with comprehensive information about the benefits, risks, and limitations of cord blood banking.

2. Sterile Technique: The collection process must be performed using a sterile technique to prevent contamination. For example, the umbilical cord should be cleaned with antiseptic before the cord blood is drawn.

3. Volume Targeting: Aiming to collect a sufficient volume of cord blood, typically between 90-150 ml, is crucial as it increases the likelihood of collecting an adequate number of stem cells.

4. Timing of Clamping: Delayed cord clamping can benefit the newborn but may reduce the volume of blood available for collection. A balance must be struck to optimize outcomes for both the baby and the cord blood unit.

5. Training of Personnel: Only trained healthcare professionals should perform the collection to ensure it is done efficiently and safely. Regular training sessions can help maintain high standards.

6. Transport and Processing: Once collected, the cord blood should be transported to the processing facility under controlled conditions and processed within a specified time frame to maintain cell viability.

7. Quality Control: Each step of the collection and storage process should have quality control measures in place, such as checks for cell count, viability, and sterility.

8. Accreditation Compliance: Adhering to the standards set by accrediting bodies, such as the AABB or FACT, ensures that the cord blood bank operates according to the highest standards.

For instance, a cord blood bank might highlight a case where a large volume of high-quality cord blood was collected, which later played a pivotal role in treating a child with leukemia. This example underscores the importance of following best practices to ensure the best possible outcome for patients in need.

The standards for cord blood collection are not just technical specifications; they represent a commitment to quality and safety in a field where the stakes are incredibly high. The best practices are a synthesis of expertise from various domains, all converging to safeguard the precious gift of life contained within each unit of cord blood.

6. Storage Protocols and Quality Assurance

In the realm of cord blood banking, the Storage Protocols and Quality Assurance measures are pivotal in ensuring the viability and safety of cord blood units for future therapeutic use. These protocols encompass a broad range of procedures and policies designed to maintain the integrity and purity of cord blood from the moment of collection through long-term storage. Quality assurance is not merely a set of guidelines but a culture that permeates every aspect of the cord blood banking process, ensuring that each unit is handled with the utmost care and precision.

From the perspective of a laboratory technician, stringent storage protocols are the backbone of their daily operations. They are responsible for the meticulous execution of these protocols, which include the controlled-rate freezing of cord blood units to prevent ice crystal formation that can damage the delicate stem cells. Similarly, a quality assurance officer would emphasize the importance of regular audits and checks to verify that storage conditions, such as temperature and humidity, are consistently within the acceptable range to preserve cell viability.

1. Temperature Monitoring: Cord blood units must be stored at temperatures below -150°C to ensure cell viability. Continuous temperature monitoring, with alarms for any deviations, is crucial.

- Example: A cord blood bank implemented a system where temperatures are recorded every 15 minutes, and any fluctuation beyond the set parameters triggers an immediate alert to the on-call staff.

2. Inventory Management: A robust inventory management system is essential for tracking each cord blood unit's location, status, and history.

- Example: Utilizing barcoding and RFID technology allows for real-time tracking and reduces the risk of misplacement or mix-ups.

3. Validation of Equipment: All storage equipment, including freezers and liquid nitrogen tanks, must undergo regular validation to ensure they are functioning correctly.

- Example: A cord blood bank conducts bi-annual validations of their freezers, simulating various conditions to test the equipment's reliability.

4. disaster Recovery planning: Having a comprehensive disaster recovery plan ensures the safety of cord blood units in case of unforeseen events.

- Example: A cord blood bank located in a hurricane-prone area has a secondary off-site storage facility to safeguard against potential natural disasters.

5. Staff Training: Continuous staff training on the latest storage protocols and quality assurance practices is vital for maintaining high standards.

- Example: A training program might include simulated emergency drills to prepare staff for quick and effective response to storage system failures.

6. Accreditation Compliance: Adherence to accreditation standards from organizations like AABB or FACT is a testament to a facility's commitment to quality.

- Example: Achieving and maintaining accreditation involves regular peer-review assessments and demonstrates a facility's dedication to excellence.

The Storage Protocols and Quality Assurance section of cord blood accreditation is a multifaceted and dynamic field that requires the collaboration of various professionals, each bringing their expertise to ensure that every cord blood unit stored today may become a life-saving treatment tomorrow. The examples provided illustrate the practical application of these protocols, highlighting their significance in the critical mission of cord blood banking.

7. Regulatory Compliance and Legal Considerations

regulatory compliance and legal considerations are pivotal in the field of cord blood banking, where the stakes are inherently high due to the involvement of human health and potential therapeutic applications. The process of cord blood collection, processing, and storage is not merely a matter of following technical protocols but also adhering to a complex web of legal requirements that vary by jurisdiction. These regulations are designed to ensure the safety, efficacy, and ethical management of cord blood, which is considered a valuable biomedical resource. They encompass a broad range of aspects, from donor consent and privacy protection to quality control and product liability. Moreover, the dynamic nature of biomedical research and healthcare policies necessitates continuous monitoring and adaptation of these legal frameworks.

1. Donor Consent and Ethical Sourcing: Cord blood banks must obtain informed consent from donors, clearly explaining the potential uses of the cord blood and the rights of the donor. For instance, the Parent's guide to Cord blood Foundation outlines the principles of voluntary donation and the importance of understanding future usage rights.

2. quality Assurance standards: Accreditation bodies like the AABB and FACT set rigorous standards for cord blood collection and storage. These standards ensure that cord blood units are collected and stored in a manner that preserves their viability and safety for future use. An example is the requirement for sterility testing to prevent contamination.

3. Traceability and Record-Keeping: Legal regulations mandate meticulous record-keeping to ensure traceability of each cord blood unit from the donor to the recipient. This is crucial for addressing any adverse events and for conducting recalls if necessary.

4. privacy and Data protection: Cord blood banks are required to protect the personal data of donors in compliance with laws such as the Health Insurance Portability and Accountability Act (HIPAA) in the U.S. Or the general Data Protection regulation (GDPR) in the EU.

5. Regulatory Licensing: Cord blood banks must be licensed by relevant health authorities, such as the U.S. Food and Drug Administration (FDA), which involves regular inspections and adherence to specific protocols for processing and cryopreservation.

6. International Standards and Agreements: With the globalization of healthcare, cord blood banks often need to comply with international standards and engage in agreements such as the Convention on Biological Diversity, which governs the transfer of biological materials across borders.

7. product Liability and Risk management: Cord blood banks must have policies in place to manage risks and address potential liability issues. This includes having insurance coverage and establishing protocols for adverse event reporting.

8. Research and Clinical Trials: When cord blood is used for research or in clinical trials, additional layers of regulation come into play, including ethical review board approvals and adherence to clinical trial protocols.

By considering these multifaceted legal requirements, cord blood banks can navigate the complex landscape of regulatory compliance, ensuring that they not only provide a life-saving service but also maintain the highest standards of ethical and legal responsibility. For example, the California Cryobank Stem Cell Services faced a lawsuit in 2017 for alleged misrepresentation of storage conditions, highlighting the importance of transparency and compliance with legal standards in maintaining trust and credibility in the industry. Such instances underscore the need for cord blood banks to be vigilant and proactive in their legal and regulatory practices.

8. Continuous Improvement and Accreditation Renewal

Continuous improvement and accreditation renewal are critical components in the field of cord blood banking, ensuring that facilities not only meet established standards at a single point in time but also continually enhance their processes and outcomes. This commitment to excellence is driven by the understanding that the field of medicine and technology is ever-evolving, and what was considered best practice yesterday may not suffice tomorrow. From the perspective of a cord blood bank, continuous improvement means regularly evaluating and updating their procedures, training programs, and quality control measures. For the patients and families who rely on these services, it translates to trust in the safety and efficacy of the cord blood units they may one day need.

From a regulatory standpoint, accreditation renewal is a rigorous process that compels cord blood banks to demonstrate their adherence to the latest standards. It's not merely a bureaucratic exercise; it's a mechanism that drives innovation and safety in the industry. Let's delve deeper into the specifics:

1. quality Management systems: Cord blood banks must have robust quality management systems (QMS) in place. This includes regular internal audits, corrective and preventive action plans, and continuous staff training. For example, a bank might implement a new barcode tracking system to reduce the risk of sample misidentification, thereby enhancing the safety of cord blood units.

2. Clinical Outcomes Monitoring: Banks are required to monitor and report on clinical outcomes. This could involve tracking the success rate of cord blood transplants and using this data to refine collection and storage methods. A bank might find that increasing the volume of collected blood improves transplant success and adjust their procedures accordingly.

3. Technological Advancements: Staying abreast of technological advancements is essential. As new preservation techniques are developed, banks must evaluate and, if appropriate, integrate them into their operations. For instance, a new cryopreservation method that increases cell viability post-thaw could be a game-changer for the industry.

4. Stakeholder Engagement: Engaging with stakeholders, including donors, recipients, and healthcare professionals, helps banks to understand and address the needs and expectations of those they serve. A patient advisory board might be established to provide insights into the patient experience and inform service improvements.

5. Benchmarking: Comparing performance against other banks and industry standards helps identify areas for improvement. If a bank's contamination rates are higher than the industry average, this would prompt a review and improvement of their sterility protocols.

6. Regulatory Compliance: With regulations constantly evolving, banks must stay informed and compliant. This might mean adjusting policies to align with new FDA guidelines on cord blood collection.

7. Accreditation Renewal Process: The process itself is designed to be comprehensive, covering everything from donor eligibility to final product release. Banks must prepare extensive documentation and undergo on-site inspections. For example, during an accreditation renewal, inspectors might identify a need for better temperature monitoring in storage facilities, leading to the installation of advanced monitoring systems.

Through these mechanisms, cord blood banks not only maintain their accreditation but also push the boundaries of what is possible in cord blood collection and storage, ultimately leading to better outcomes for patients worldwide. Continuous improvement and accreditation renewal are not just about maintaining the status quo; they are about setting new standards of excellence and ensuring that every cord blood unit is as safe and effective as possible.

9. Innovations and Trends

Cord blood banking, the process of collecting and storing the blood from a newborn's umbilical cord, has been a beacon of hope for families and individuals seeking future medical security. As we look towards the future, this field is poised for transformative changes, driven by technological advancements, evolving medical practices, and a deeper understanding of stem cell applications. The promise of cord blood in treating a myriad of conditions, from blood disorders to neurological diseases, has spurred a wave of innovation aimed at maximizing its potential.

From the perspective of medical professionals, the integration of advanced cryopreservation techniques is set to enhance the viability and longevity of stored cord blood. Researchers are exploring the frontiers of regenerative medicine, where cord blood cells could be engineered to repair damaged tissues or organs. Ethical considerations also play a pivotal role, as the industry navigates the balance between commercial interests and patient welfare.

For patients and families, the decision to bank cord blood is becoming increasingly informed by data-driven insights. The emergence of personalized medicine has the potential to tailor treatments using cord blood to individual genetic profiles, increasing the efficacy of interventions. Moreover, public awareness campaigns are demystifying the process, making it more accessible to diverse populations.

Here are some key innovations and trends shaping the future of cord blood banking:

1. automation in Cord blood Processing: Automation technologies are revolutionizing how cord blood is processed, leading to higher cell recovery rates and reduced contamination risks. For example, the Sepax system is an automated, closed processing system that can efficiently separate stem cells from cord blood without manual intervention.

2. Expansion of Treatable Conditions: With ongoing clinical trials, the list of diseases treatable with cord blood is expanding. Conditions like autism and cerebral palsy are under investigation, showing promising preliminary results.

3. public-Private partnerships: To increase the availability of matched cord blood units, collaborations between public banks and private entities are on the rise. These partnerships aim to create a more robust inventory, exemplified by the alliance between Be The Match and various private banks.

4. Genetic Screening Advancements: The integration of next-generation sequencing technology allows for detailed genetic screening of cord blood units. This ensures a better match for transplant patients and may even predict potential future health issues.

5. Regenerative Medicine Breakthroughs: Cord blood is at the forefront of regenerative medicine research. Scientists are exploring its use in creating induced pluripotent stem cells (iPSCs), which have the potential to differentiate into any cell type for repair and regeneration.

6. Global Accreditation Standards: The establishment of global accreditation standards, such as those set by the Foundation for the Accreditation of Cellular Therapy (FACT), ensures consistency in quality and safety across the industry.

7. Educational Initiatives: To combat misinformation and increase participation, educational initiatives are being launched. These programs aim to inform expectant parents about the benefits and processes involved in cord blood banking.

The future of cord blood banking is marked by a confluence of innovation, collaboration, and education. As the industry evolves, it holds the promise of unlocking new therapeutic avenues and enhancing the quality of life for patients around the world. The ongoing commitment to research and ethical practices will be crucial in realizing the full potential of this life-saving resource.

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