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Related Concept Videos

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Gene therapy is a technique where a gene is inserted into a person’s cells to prevent or treat a serious disease. The added gene may be a healthy version of the gene that is mutated in the patient, or it could be a different gene that inactivates or compensates for the patient’s disease-causing gene. For example, in patients with severe combined immunodeficiency (SCID) due to a mutation in the gene for the enzyme adenosine deaminase, a functioning version of the gene can be...
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Stem cell therapy is a method used in regenerative medicine to repair and restore function to damaged tissues and organs. Stem cells have the potential to proliferate and differentiate into various tissue types, making them ideal candidates for tissue regeneration. For example, hematopoietic stem cell transplants are commonly used in blood cancer treatment to replenish damaged bone marrow and restore healthy blood cells.
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Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production
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From Vision to Viability: Developing Infrastructure for Cell and Gene Therapy Programs.

Zahra Mahmoudjafari1, Joseph McGuirk1, Nausheen Ahmed1

  • 1The University of Kansas Cancer Center, Kansas City, Kansas.

Transplantation and Cellular Therapy
|January 9, 2026
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Summary
This summary is machine-generated.

Implementing cell and gene therapies (CGTs) requires robust institutional infrastructure. This framework outlines key domains for safe, efficient, and sustainable CGT program delivery, ensuring optimal patient care and access.

Keywords:
CAR T-cell therapyCell and gene therapyCellular therapy infrastructureClinical operationsFinancial and reimbursement strategyOncology program developmentOperational sustainabilityQuality and safety frameworksWorkforce development

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Area of Science:

  • Oncology
  • Regenerative Medicine
  • Health Systems Management

Background:

  • Cell and gene therapies (CGTs) represent a significant advancement in treating complex diseases.
  • Implementing CGTs necessitates specialized infrastructure, multidisciplinary coordination, and regulatory compliance.
  • Limited literature exists on operational strategies for establishing CGT programs.

Purpose of the Study:

  • To present a practical framework for building institutional infrastructure to support CGT delivery.
  • To outline actionable strategies for operationalizing CGT programs across clinical, operational, and financial aspects.
  • To guide health systems in establishing safe, efficient, and sustainable CGT programs.

Main Methods:

  • Descriptive analysis and synthesis of best practices from early adopters and accreditation standards.
  • Development of a structured roadmap covering strategic planning, governance, and operational readiness.
  • Conceptual and operational framework without statistical analysis.

Main Results:

  • A framework with eight interdependent domains for successful CGT program implementation.
  • Key domains include strategic planning, operational readiness, product access, pharmacy integration, financial strategies, technology integration, quality management, and outreach.
  • The framework provides a blueprint for mitigating risks, enhancing patient safety, and ensuring timely therapy access.

Conclusions:

  • CGTs offer transformative potential but require deliberate infrastructure development.
  • Multidimensional readiness across strategic, operational, and financial domains is crucial for high-quality, equitable CGT delivery.
  • This framework serves as a guide for centers implementing CGT programs in a rapidly evolving landscape.