21 CFR Part 50 Compliant 21 CFR 50.55 Pediatric

PEDIATRIC PATIENT INFORMED CONSENT

Wharton's Jelly Mesenchymal Stem Cell (WJ-MSC) Exosome Administration

For patients under 18 years of age. Requires parental or legally authorized representative consent.

Minor Patient Information

Parent / Legally Authorized Representative

Second Parent/Guardian (if applicable, per 45 CFR 46 Subpart D)

1Product Identification

  • •WJ-MSC derived exosomes, biologic product
  • •Regulated under Section 351(a) of the Public Health Service Act
  • •FDA Drug Master File on record with the manufacturer
  • •Manufactured under cGMP (21 CFR 210/211, 21 CFR 600 series)
  • •Investigational status, not FDA-approved for any indication

2Nature of Treatment

  • •Acellular biologic containing extracellular vesicles
  • •Routes of administration as ordered by the treating physician
  • •Dose, frequency, and duration documented in the chart
  • •Treatment is elective

3Investigational Disclosure

  • •The product has not received a Biologics License Application (BLA) approval
  • •Long-term safety and efficacy are not fully characterized
  • •Outcomes vary between patients
  • •No therapeutic benefit is guaranteed
  • •Pediatric-specific safety data are limited for WJ-MSC exosome products

4Known and Possible Risks

  • •Pain, redness, swelling, or bruising at the administration site
  • •Allergic or hypersensitivity reaction, including anaphylaxis
  • •Infection
  • •Fever, chills, headache, fatigue, nausea
  • •Inflammatory or immune response
  • •Vascular events with intravenous administration
  • •Unknown long-term risks, including effects on growth and development
  • •Theoretical risk of tumorigenicity, not observed in published WJ-MSC exosome literature
  • •Age-specific immune responses that differ from adult populations

5Possible Benefits

  • •Potential reduction in tissue inflammation
  • •Potential support of tissue repair processes
  • •Potential symptom relief
  • •Benefits are not guaranteed

6Alternatives

  • •Standard pharmacologic therapy
  • •Surgical intervention
  • •Physical therapy and rehabilitation
  • •Pain management
  • •Age-appropriate standard of care treatments
  • •No treatment

7Voluntary Nature

  • •Participation is voluntary
  • •Refusal will not affect access to other medical care
  • •Withdrawal is permitted before administration
  • •Once administered, the product cannot be retrieved
  • •The parent or legally authorized representative has the right to withdraw the minor at any time

8Financial Terms

  • •Treatment is self-pay unless documented otherwise
  • •Insurance reimbursement is not guaranteed
  • •Total cost has been disclosed in writing
  • •No federal healthcare program funds are billed for this service in compliance with 42 USC 1320a-7b (Anti-Kickback Statute) and 42 USC 1395nn (Stark Law)

9Privacy and HIPAA

  • •Health information is protected under 45 CFR 160 and 164
  • •De-identified outcome data are used for quality assurance, registry, and internal research
  • •Identifiable disclosures require separate written authorization from the parent or legally authorized representative
  • •Minor's health records are subject to additional state protections where applicable

10Treatment-Related Injury

  • •The provider will coordinate medical care for any treatment-related injury
  • •No automatic financial compensation is offered
  • •Parent or legally authorized representative retains all legal rights under state and federal law
  • •This consent does not waive claims for gross negligence or willful misconduct

11New Information

  • •Parent or legally authorized representative will be notified of new findings affecting willingness to continue
  • •Updated FDA guidance affecting product classification will be communicated
  • •Any new pediatric safety data will be disclosed promptly

12Right to Ask Questions

  • •Questions have been answered by the treating physician
  • •Parent or legally authorized representative has been given written and verbal information
  • •Parent or legally authorized representative confirms understanding before signing
  • •The minor has been provided age-appropriate information per 21 CFR 50.55

Parent / Legally Authorized Representative Attestation

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Minor Patient Assent

Per 21 CFR 50.55, when the minor is capable of providing assent, the investigator must obtain the minor's affirmative agreement. Assent is required for children who have sufficient understanding, typically ages 7 and older.

Minor's Understanding (age-appropriate language):

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Physician Attestation

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Regulatory Authority

21 CFR Part 50 (Informed Consent)
21 CFR 50.55 (Requirements for Permission by Parents or Guardians and for Assent by Children)
21 CFR Part 1271 (HCT/P Regulations)
21 CFR Part 312 (Investigational New Drug Application, where applicable)
45 CFR Part 46 (Common Rule)
45 CFR 46 Subpart D (Additional Protections for Children)
45 CFR Parts 160 and 164 (HIPAA)
Section 351(a), Public Health Service Act
42 USC 1320a-7b (Anti-Kickback Statute)
42 USC 1395nn (Stark Law)
Texas Health and Safety Code Chapter 241
Texas Family Code Chapter 151 (Parental Rights and Duties)
Texas Medical Disclosure Panel, 25 TAC Chapter 601
Texas Occupations Code Chapter 164

Consent Form Incomplete

Complete all required fields, check all attestation boxes, and provide signatures to enable PDF download.

EXOBOT.IO Pediatric Informed Consent Document, Version 1.0

Generated in compliance with 21 CFR Part 50, 21 CFR 50.55, 45 CFR Part 46 Subpart D, and Section 351(a) PHS Act

This document is for research, investigational, and clinical documentation purposes.

Consult a board-certified attorney licensed in your jurisdiction before relying on any legal or regulatory interpretation presented in this document.