Regenerative Biologics for Spinal Surgery & Interventional Pain Practices

Spinal Surgery · Interventional Pain · Neurosurgery · Spine Rehab

UCT-MSC Biologics for Spinal & Interventional Pain Practices

Stem Nova Network supplies 25M hUCT-MSC stem cells to licensed spinal surgery centers, interventional pain physicians, neurosurgeons, and spine-focused orthopedic practices. These products are supplied as research-grade biologics for licensed professional use only and have not been approved by the United States Food and Drug Administration.

Every lot is manufactured to pharmaceutical-grade quality standards with full lot-specific documentation — including post-thaw viability, flow cytometry identity markers, sterility, endotoxin, full viral screening panel, and mycoplasma testing to the intrathecal safety threshold of ≤ 0.02.

Important: These products are not FDA-approved drugs or therapeutic agents and are not intended to diagnose, treat, cure, or prevent any disease or condition. All clinical decisions — including patient selection, dosing, route of administration, and protocol design — are at the sole discretion and professional responsibility of the licensed practitioner in accordance with applicable federal and state regulations.

Delivery Routes — Procedural Reference

The following routes are referenced in the published clinical and research literature for MSC biologic administration. Route selection, procedural technique, patient suitability, and all clinical decisions are entirely at the discretion of the licensed practitioner.

Lower Complexity

Paraspinal

Administration into the paravertebral musculature adjacent to the affected spinal level. No dural puncture. Fluoroscopy recommended for accurate placement. Cell washing required prior to administration.

Intermediate

Epidural (Peridural)

Administration into the epidural space without dural puncture. Standard epidural technique with fluoroscopic guidance recommended. Cell washing required prior to administration.

Advanced

Intradiscal

Direct administration into the nucleus pulposus. Fluoroscopy required. Practitioner proficiency with discography technique required. Cell washing required. Hydrogel co-administration may be considered at practitioner discretion.

High Complexity

Intrathecal

Direct introduction into the subarachnoid space. CSF pressure testing required prior to administration. Mandatory cell washing. Mycoplasma specification ≤ 0.02 required. All decisions at sole practitioner discretion.

Administration Sequencing

For some patients, the physician may consider combining a localized spinal procedure with same-day systemic administration, based on the physician's clinical judgment, patient history, and treatment goals. Treatment planning is individualized and entirely at the discretion of the licensed practitioner.

This therapy has not been approved by the United States Food and Drug Administration.

Product — 25M hUCT-MSC Vial

25M hUCT-MSC Vial — Research-Grade Biologic · Licensed Professional Use Only · Not FDA-Approved

Human umbilical cord tissue–derived mesenchymal stem cells sourced from first-pregnancy Wharton's Jelly donors. Supplied as a research-grade biologic for licensed professional use only.

  • 25 Million MSCs per vial · 97% post-thaw viability (lot-documented)
  • CD90: 100% · CD166: 100% — flow cytometry confirmed, ISCT-defined MSC identity markers
  • Endotoxin: 0.935 EU/mL (specification ≤ 10 EU/mL per USP <85>)
  • Sterility: Negative per 21 CFR 610.12 · Mycoplasma: Negative at ≤ 0.02
  • Viral panel: HCV, HIV, HBV, HTLV, CMV, EBV, HHV, HPV, B19 — all Negative
  • FDA Type II Drug Master File on record · AATB-Accredited US facility · cGMP-aligned
  • Stored LN₂ vapor phase ≤ -140°C · Shipped on dry ice · Lot-specific CoA with every order

Wholesale pricing to enrolled licensed professionals · Volume tiers at 4–9 and 10+ vials

Cell Washing — Required for All Spinal Routes

Mandatory prior to any spinal, epidural, or intradiscal administration: UCT-MSC vials are cryopreserved in DMSO. The cryoprotectant must be removed before administration into the spinal space. See SNN-CP-002 UCT-MSC Cell Washing & Preparation Protocol — available to enrolled wholesale accounts upon request.

Lot-Specific Quality Documentation

Parameter Specification SNN Lot-Documented Result
Post-Thaw Viability ≥ 70% (industry standard) 97%
CD90 Expression ≥ 80% (ISCT standard) 100%
CD166 Expression ≥ 80% (ISCT standard) 100%
Endotoxin ≤ 10 EU/mL (USP <85>) 0.935 EU/mL
Mycoplasma (Intrathecal threshold) ≤ 0.02 Confirmed ≤ 0.02
Sterility Negative (21 CFR 610.12) Negative
Full Viral Screening Panel Negative (9 markers) All Negative

Practice Types We Supply

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Interventional Pain Physicians

Licensed practitioners already performing fluoroscopic spinal procedures seeking a verified, fully documented biologic supplier for research-grade UCT-MSC products.

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Neurosurgeons & Spine Surgeons

Licensed surgeons seeking research-grade biologic supply with full lot documentation including viral panel, mycoplasma, sterility, and FDA Type II Drug Master File on record.

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Orthopedic Spine Specialists

Licensed orthopedic practitioners incorporating biologic products into their existing spinal procedure workflows under their professional scope and applicable state medical board authority.

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Veteran & Military Care Practices

Licensed practices serving veteran and active-duty military patients. Volume pricing available. Contact us regarding documentation support for VA Community Care Network practices.

Enroll Your Practice for Wholesale Access

Lot-specific CoAs, full viral panel documentation, mycoplasma-verified lots, and dedicated support — available to licensed professionals upon credential verification. Most practices approved within 24 hours.

Enroll Your Practice Today → Contact Our Clinical Team

Related Resources

Regulatory Notice: Stem Nova Network biologics are supplied as research-grade biologics for licensed professional use only. These products are not FDA-approved drugs or therapeutic agents and are not intended to diagnose, treat, cure, or prevent any disease or condition. These products have not been approved by the United States Food and Drug Administration for spinal, intrathecal, epidural, or intradiscal administration. All clinical decisions including patient selection, dosing, route selection, and protocol design are at the sole discretion and professional responsibility of the licensed practitioner in accordance with applicable federal and state regulations including 21 CFR Part 1271 and all applicable state medical board requirements. Practitioners are solely responsible for ensuring compliance with all applicable laws. FDA Type II Drug Master File documentation available upon request. · info@stemnovanetwork.com · 281-541-0047 · stemnovanetwork.com