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.

Exosome Protocol Robot

INFORMED CONSENT FOR EXOSOME THERAPY

Exobot.io

Mesenchymal Stem Cell-Derived Exosomes

Patient Information

Patient Full Name

Date of Birth

Medical Record / Case No.

Regulatory Notice

Exosome Therapy is a biologic product manufactured under cGMP standards and registered with the FDA under a Drug Master File (Section 351(a) of the Public Health Service Act). This therapy has not received FDA approval for treatment of your specific condition. Your physician has determined, in their independent clinical judgment, that this therapy may benefit you. You have the right to ask questions before signing this consent.

1. DESCRIPTION OF TREATMENT

Exosome Therapy uses exosomes derived from Wharton's Jelly mesenchymal stem cells (WJ-MSCs). Exosomes are small signaling vesicles that carry growth factors, proteins, and genetic material. They are produced under pharmaceutical-grade cGMP manufacturing conditions. The product is administered by your physician via intravenous (IV) infusion or direct injection, depending on your treatment plan.

Standard therapeutic dose: 5 mL containing 100 billion exosomes (20 billion per mL).

2. GOALS OF TREATMENT

The goal is to support your body's natural repair and anti-inflammatory processes. Outcomes vary. No physician or staff member is authorized to guarantee results. Any representation of guaranteed outcomes is unauthorized and should be reported to your treating physician immediately.

3. KNOWN RISKS AND POSSIBLE ADVERSE EFFECTS

All medical procedures carry risk. The following risks have been identified with exosome therapy:

Common Reactions (Reported in Clinical Experience)

- Mild fatigue lasting 24-72 hours
- Low-grade fever (under 101 F) within 24 hours of infusion
- Redness, bruising, or soreness at the infusion site
- Temporary nausea or headache

Less Common but Serious Risks

- Allergic or hypersensitivity reaction, including anaphylaxis
- Infection at the administration site
- Systemic immune response (fever, chills, rigors)
- Unknown long-term effects: This therapy is not FDA approved for this indication. Long-term safety data is limited.

Theoretical Risks Under Investigation

- Potential interaction with existing medications or active inflammatory conditions
- Immunogenicity: unknown response in patients with autoimmune disorders
- Risks specific to your medical history as identified by your physician

EMERGENCY CONTACT: If you experience difficulty breathing, severe swelling, chest pain, or loss of consciousness following treatment, call 911 immediately and then notify your treating physician.

4. ALTERNATIVES TO TREATMENT

You are not required to receive Exosome Therapy. Alternatives include:

- Continued conservative management (physical therapy, medication, pain management)
- Other interventional procedures as recommended by your physician
- Watchful waiting with no active intervention
- Referral to another specialist for a second opinion

Choosing not to receive this therapy will not affect the quality of other care you receive at this practice.

5. VOLUNTARY CONSENT AND RIGHT TO WITHDRAW

Your participation is entirely voluntary. You withdraw consent at any time before the therapy begins without penalty or impact on your care. You cannot withdraw consent after administration has started. Once you sign this form, your physician will review it with you before proceeding. Ask all questions before signing.

6. FINANCIAL DISCLOSURE

Exosome Therapy is not covered by Medicare, Medicaid, or most commercial insurance plans. Payment is your responsibility. Fees were disclosed to you in a separate financial agreement. Signing this consent does not waive any financial obligation already agreed to in writing.

If you are receiving treatment through a personal injury lien program, the terms of your Letter of Protection govern your financial obligations to this practice.

7. PRIVACY AND HIPAA AUTHORIZATION

Your protected health information (PHI) is handled under the practice's HIPAA Notice of Privacy Practices, which you received separately. De-identified outcome data from your treatment is used for internal quality improvement. No identifiable information is shared with third parties without your written authorization.

If your treatment is related to a personal injury claim, you authorize disclosure of treatment records to your attorney of record and their designated insurers solely for purposes of your legal claim.

8. PATIENT ACKNOWLEDGMENTS

By signing below, you confirm that:

You received and read this consent form.

Your physician explained the procedure, risks, benefits, and alternatives.

You had the opportunity to ask questions and received satisfactory answers.

You are 18 years of age or older, or your authorized representative has signed below.

You are not under duress and are signing voluntarily.

You understand this therapy is not FDA-approved for your specific condition.

You understand no outcomes have been guaranteed to you.

Signatures

Patient or Authorized Representative

Patient / Authorized Representative Signature

Draw your signature below

Relationship to Patient (if Authorized Representative)

Witness

Witness Signature

Witness draws signature below

Printed Name of Witness

Treating Physician

I have explained the nature of this procedure, the risks, the benefits, and the available alternatives to the patient. I have answered all questions to the best of my ability.

Physician Signature

Physician draws signature below

Physician Printed Name

License No.

Minor Patient Section (Complete Only If Patient Is Under 18)

Download Completed Consent

Complete all acknowledgments and sign to download.

Version 1.0 | Exobot.io | This form is reviewed annually for compliance with applicable federal and state law.

Section 351(a), Public Health Service Act, 42 U.S.C. 262.

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