What is the 351(a) pathway for exosome products?

Section 351(a) of the Public Health Service Act, 42 U.S.C. 262(i), defines exosomes intended for therapeutic use as biological products requiring a Biologics License Application (BLA) for commercial distribution. As of April 2026, zero exosome products have received FDA BLA approval.

What are hUCMSC-derived exosomes?

hUCMSC-derived exosomes are extracellular vesicles (30-150nm) isolated from human umbilical cord mesenchymal stem cells (Wharton's Jelly). They carry bioactive cargo including miRNA, mRNA, and proteins with demonstrated paracrine signaling properties in preclinical and clinical research.

What administration routes are available for exosome protocols?

Three primary administration routes are used in exosome research protocols: intravenous (IV) infusion for systemic delivery, nebulized inhalation for pulmonary conditions, and direct injection for localized applications including intra-articular, intrathecal, and intracardiac delivery.

21 CFR Part 50 Compliant

PATIENT INFORMED CONSENT

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

Patient Information

Patient Name

Date of Birth

MRN (Optional)

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

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
•Theoretical risk of tumorigenicity, not observed in published WJ-MSC exosome literature

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
•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

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

10Treatment-Related Injury

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

11New Information

•Patient will be notified of new findings affecting willingness to continue
•Updated FDA guidance affecting product classification will be communicated

12Right to Ask Questions

•Questions have been answered by the treating physician
•Patient has been given written and verbal information
•Patient confirms understanding before signing

Patient Attestation

I am at least 18 years of age and legally competentI have read or had read to me this consentI have had the opportunity to ask questionsI voluntarily consent to WJ-MSC exosome administration

Patient Signature

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Witness Signature

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Date

Time

Witness Date

Physician Attestation

I have personally explained the nature, risks, benefits, and alternativesThe patient demonstrated understandingI have answered all questions

Physician Signature

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Physician Date

Printed Name

Texas Medical License #

Regulatory Authority

21 CFR Part 50 (Informed Consent)

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 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 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 Informed Consent Document, Version 1.0

Generated in compliance with 21 CFR Part 50, 45 CFR Part 46, 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.