JadiCells for chest pain in COPD

Regulatory Angle (Florida Law – Effective July 1, 2025)

The new legislation permits licensed Florida physicians to administer stem cells derived from umbilical cord, placenta, bone marrow, or adipose tissue for pain under a standard of care model without an IND or FDA preapproval.

Using JadiCells for chest pain in COPD:

  • Chest pain in COPD is well-documented — from hyperinflation, pleuritic inflammation, or secondary musculoskeletal strain.
  • If your diagnosis is “chronic pain associated with COPD,” the physician has a valid justification to administer stem cells under the state’s “pain” exception.
  • Treating the underlying inflammation (which JadiCells do) could be framed as mechanistic support, not an unapproved therapy for COPD per se.

This is a clever way to enter the market under the umbrella of pain management, while delivering broader therapeutic benefit.

Clinical Justification

JadiCells possess:

  • Anti-inflammatory cytokine profiles (TGF-β, IL-10)
  • Mitochondrial transfer potential to restore energy deficits in inflamed respiratory tissues
  • Ability to reduce neurogenic inflammation, which plays a role in pain signaling
  • Immunomodulation of macrophage activity in lung parenchyma and pleura

We can build a credible clinical argument that treating pain via JadiCells also has spillover benefits for pulmonary function, quality of life, and oxygenation.

Commercial Application

  • Framed as a regenerative pain program with targeted lung benefits.
  • Offer a licensing or supply agreement to Florida physicians who:
    • Treat pain in COPD patients,
    • Document appropriate diagnosis codes (e.g., ICD-10 R07.1, R07.2, R07.89, M54.6),
    • Follow state rules for informed consent, documentation, and traceability.
  • We could also conduct outcomes tracking (spirometry, 6MWT, pain VAS scale), creating data to support future IND amendments or a real-world evidence dossier.

Physician Guide: Use of JadiCells for Pain Management in COPD Patients
under Florida Statute (Effective July 1, 2025)

Overview
Under new legislation effective July 1, 2025, licensed Florida physicians may administer stem cell-based therapies for the treatment of pain, including pain related to chronic diseases, without the requirement of an IND or FDA pre-approval. This guide provides a clinical and legal framework for the use of JadiCells in managing chest pain associated with COPD, while also addressing the underlying inflammation and pathology.

  1. Legal Authority
  • Statute: Florida HB 1617 (2025)
  • Permissible Uses: Autologous or allogeneic stem cells derived from umbilical cord, placenta, bone marrow, or adipose tissue
  • Indication: “Treatment of pain” by licensed physicians within the scope of practice
  • Documentation Required: Diagnosis, treatment rationale, consent, and patient follow-up
  1. Clinical Justification: Chest Pain in COPD
  • Chest pain is a recognized comorbidity in COPD, often stemming from:
    • Hyperinflation and musculoskeletal strain
    • Pleuritic inflammation
    • Secondary respiratory muscle fatigue
  • ICD-10 codes to support this include:
    • R07.1 (Chest pain on breathing)
    • R07.2 (Precordial pain)
    • R07.89 (Other chest pain)
    • M54.6 (Thoracic spine pain)
  • Treatment with JadiCells may reduce systemic and localized inflammation contributing to pain perception
  1. Product Information: JadiCells
  • Allogeneic MSCs derived from umbilical cord tissue
  • Characterized by expression of:
    • MSC markers: CD73, CD90, CD105, CD54, CD106, STRO-1, CD10, CD146
    • Hematopoietic markers: CD34, CD133
  • Manufactured under cGMP conditions with batch-level Certificates of Analysis
  • Dosing: 100 million cells per infusion (suggested)
  1. Patient Selection & Documentation
  • Adult patients with physician-diagnosed COPD (Stage II-IV)
  • Subjective chest pain (VAS ≥ 4/10)
  • Pain not responsive to conservative management (NSAIDs, pulmonary rehab)

Intake Checklist:

  • COPD diagnosis confirmation
  • Pain history and baseline scoring
  • Medication history and comorbidity assessment
  • Consent for non-FDA-approved use

Follow-Up Tools:

  • VAS/NRS weekly score tracking
  • Functional status updates (6MWT if available)
  • Pulmonary symptom diary
  1. Consent and Liability Notes
  • Clearly document:
    • That the treatment is not FDA-approved
    • That benefits are investigational and not guaranteed
    • That the indication is pain, not curative COPD reversal
  • Maintain HIPAA-compliant records of all administration and adverse event reporting

    Disclaimer: This guide is not legal advice. Physicians must consult with their counsel and professional liability carrier before initiating stem cell-based interventions.