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

Category 17

Questions Patients Should Ask Clinics

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

  • 17.1Product identity
    In preparation
    1. · What exactly is being administered?
    2. · Is it a cell product, EV product, tissue product, or conditioned medium?
    3. · What is the tissue source?
    4. · Is it autologous or allogeneic?
    5. · Who manufactured it?
    6. · What is the batch number?
  • 17.2Regulatory status
    In preparation
    1. · Is this product FDA-approved for my condition?
    2. · If investigational, what is the IND number?
    3. · Who is the sponsor?
    4. · Which IRB approved the study?
    5. · Where is the trial registered?
    6. · May I review the FDA acknowledgment?
  • 17.3Manufacturing and testing
    In preparation
    1. · Was it manufactured under GMP?
    2. · What sterility testing was performed?
    3. · Was it tested for endotoxin and mycoplasma?
    4. · What are the identity and purity specifications?
    5. · What is the viability?
    6. · What potency assay was used?
  • 17.4Evidence
    In preparation
    1. · What peer-reviewed trials studied this exact product?
    2. · Were they randomized and controlled?
    3. · How many patients were treated?
    4. · What objective benefits occurred?
    5. · How long were patients followed?
    6. · Were negative results published?
  • 17.5Risks
    In preparation
    1. · What serious adverse events have occurred?
    2. · What risks remain unknown?
    3. · What are the procedure-specific risks?
    4. · Could the therapy interfere with future treatment?
    5. · Who manages complications?
    6. · Where would emergency care occur?
  • 17.6Treatment plan
    In preparation
    1. · What dose will I receive?
    2. · How was that dose selected?
    3. · What route will be used?
    4. · Why is repeat dosing recommended?
    5. · What other treatments are required?
    6. · What follow-up is included?
  • 17.7Costs
    In preparation
    1. · What is the total cost?
    2. · Are travel and follow-up included?
    3. · Who pays for complications?
    4. · Is any portion refundable?
    5. · Is insurance expected to pay?
    6. · Am I paying to participate in research?
  • 17.8Alternatives
    In preparation
    1. · What is the current standard of care?
    2. · What happens without this intervention?
    3. · Are less risky options available?
    4. · Are legitimate trials available?
    5. · Should I obtain a second opinion?
  • 17.9Documentation to request
    In preparation
    1. · Informed-consent form
    2. · Investigator brochure
    3. · Protocol summary
    4. · Certificate of analysis
    5. · Manufacturer information
    6. · Regulatory documentation
    7. · Written follow-up plan