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Back to SteamcellSCE Educational LibraryStructured Educational Evidence Review · Dr. Mack Sullivan

Category 2

Established Versus Experimental Therapies

8 topics planned. Each topic is published as a Professional and Patient edition only after explicit author approval.

  • 2.1What qualifies as an established therapy?
    In review
    1. · Regulatory authorization
    2. · Reproducible clinical benefit
    3. · Accepted indications
    4. · Standardized manufacturing
    5. · Professional guidelines
    6. · Postmarketing surveillance
  • 2.2Hematopoietic stem-cell transplantation
    In review
    1. · Bone-marrow transplantation
    2. · Peripheral-blood stem-cell transplantation
    3. · Cord-blood transplantation
    4. · Autologous transplantation
    5. · Allogeneic transplantation
  • 2.3Established hematopoietic indications
    In review
    1. · Leukemias
    2. · Lymphomas
    3. · Multiple myeloma
    4. · Myelodysplastic syndromes
    5. · Aplastic anemia
    6. · Hemoglobinopathies
    7. · Congenital immunodeficiencies
    8. · Selected inherited metabolic diseases
  • 2.4Transplantation fundamentals
    In review
    1. · Donor selection
    2. · HLA matching
    3. · Conditioning regimens
    4. · Stem-cell mobilization
    5. · Collection and processing
    6. · Engraftment
    7. · Immune reconstitution
    8. · Long-term follow-up
  • 2.5Transplantation complications
    In review
    1. · Graft-versus-host disease
    2. · Graft failure
    3. · Infection
    4. · Organ toxicity
    5. · Infertility
    6. · Secondary malignancies
    7. · Relapse
    8. · Late immune complications
  • 2.6Experimental cell therapies
    In review
    1. · MSC-based therapies
    2. · Pluripotent-cell-derived products
    3. · Neural progenitor therapies
    4. · Cardiac cell therapies
    5. · Retinal cell therapies
    6. · Pancreatic islet-cell replacement
    7. · Tissue-engineered products
  • 2.7Understanding regulatory status
    In review
    1. · Approved product
    2. · Investigational product
    3. · IND authorization
    4. · Clinical-trial registration
    5. · Expanded access
    6. · Off-label use
    7. · Unapproved commercial treatment
  • 2.8Why a clinical trial is not proof
    In review
    1. · Early-phase safety studies
    2. · Lack of control groups
    3. · Small sample size
    4. · Surrogate endpoints
    5. · Publication bias
    6. · Incomplete follow-up
    7. · Trial registration versus regulatory approval