Discover Biologics

Spina Bifida

The purpose of this website is to provide educational information for practitioners on biologic materials, regulatory considerations, and general best practices. This content is intended for professional education only and does not constitute medical advice or approved treatment recommendations.

Purpose

This protocol outlines the investigational use of extracellular matrix–derived biologics (EXM) in combination with PV-MAX exosome therapy as an adjunctive regenerative approach for patients with spina bifida. The goal is to support neural signaling, reduce neuroinflammation, and promote systemic repair mechanisms. This therapy is not intended to cure spina bifida and is considered investigational and off-label.

Patient Eligibility

  • Diagnosed spina bifida (myelomeningocele, meningocele, or spina bifida occulta)

  • Pediatric or adult patients per clinic policy

  • Medically stable without active infection

  • Informed consent obtained

Contraindications

  • Active systemic infection

  • Known hypersensitivity to biologic components

  • Active malignancy

  • Pregnancy unless approved by Medical Director

  • Coagulopathy or anticoagulation contraindicating IM injection

Dosing Considerations

EXM: 2 cc total, administered intramuscularly (IM)

PV-MAX: 3 cc total, administered intramuscularly (IM)

Total Injectate Volume: 5 cc

Preparation and Handling

Biologics should be thawed according to manufacturer specifications. Glycerol-based products do not require washing. Products must be used within 15–30 minutes post-thaw. Strict sterile technique must be maintained throughout preparation and administration.

Regulatory Disclaimer

Preferred injection site is the gluteal musculature due to volume tolerance and systemic absorption. Alternative sites include the deltoid (maximum 2 cc per deltoid).

Recommended Injection Distribution:

EXM: 1 cc per glute bilaterally

PV-MAX: 1.5 cc per glute bilaterally

Use a 22–25 gauge needle for IM injection.Aspirate prior to injection and inject slowly. Observe the patient for 15–30 minutes post-procedure.

Treatment Schedule

Initial treatment consists of a single administration. Repeat dosing may be considered every 4–8 weeks based on clinical response. Re-evaluation is recommended after 2–3 treatment sessions.

Regulatory Statement

This protocol represents off-label and investigational use of biologic products. All treatments must comply with applicable state and federal regulations, institutional policies, and informed consent requirements. No claims of disease cure are made

Risks and Safety

Potential risks include injection site discomfort, bruising, or transient inflammatory response. No known tumorigenic risk has been identified based on the acellular nature of the biologics; however, long-term outcomes remain under investigation.

Medical Oversight

All treatments must be ordered and supervised by a licensed physician experienced in regenerative medicine.

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Disclaimer

The information on this website is provided solely for informational purposes and has not been reviewed or approved by the FDA or any other regulatory authority. It does not constitute medical advice, diagnosis, treatment, or any guarantees of medical outcomes and should not be used as a substitute for formal medical education and training, nor as a substitute for consultation with qualified healthcare professionals. Similarly, the content does not provide legal advice or guidance on regulatory compliance and should not replace consultations with qualified legal professionals.

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