Why safety comes first

Stem cell treatments are being investigated for multiple musculoskeletal, neurological and dermatological conditions. Ethical clinical use requires three pillars: patient safety, product quality and regulatory compliance. Without these, risks increase and outcomes are harder to interpret responsibly.

Safety principles before any procedure

1) Pre-treatment assessment

• Comprehensive medical history: comorbidities, allergies and current medications (including anticoagulants and immunosuppressants).
• Clear diagnosis with defined inclusion/exclusion criteria.
• Baseline documentation using objective scales (e.g., VAS, WOMAC, ODI) to track progress.

2) Product quality and traceability

• Source and processing: distinguish minimal manipulation from products that require authorization as advanced therapies.
• Quality controls: sterility, identity, viability, potency and absence of contaminants.
• Chain of custody: batch records, transport and storage under validated conditions.

3) Informed consent and realistic expectations

• Explain potential benefits, known and unknown risks, alternatives and the possibility of non-response.
• Avoid unsupported promises or success rates; set clear, measurable functional goals instead.

Side effects: what has been reported

Across controlled clinical studies, the most frequently reported adverse events are transient and of low severity. Their type and frequency vary by indication, cell type, administration route and patient characteristics.

• Common (usually mild and self-limited): local pain or swelling at the application site, mild flu-like symptoms, headache, low-grade fever, myalgias.
• Less frequent (require monitoring): hypersensitivity reactions, local or systemic infection, post-infusion symptoms (chills, malaise).

Note: Risk increases when products lack quality controls or are used outside regulated frameworks. Proper patient selection and standardized protocols help reduce adverse events.

Contraindications: absolute and relative

Applicability varies by indication and protocol. The final decision rests with the treating medical team.

Absolute

• Active systemic infection or infection at the application site.
• Known hypersensitivity to product components.
• Inability to provide informed consent.

Relative

• Uncontrolled coagulopathies or anticoagulation that precludes interventional techniques.
• Active or recently treated malignancy (requires prior onco-hematology evaluation).
• Significant immunodeficiency or high-dose immunosuppressive therapy.
• Pregnancy and breastfeeding (caution given limited specific evidence).
• Decompensated comorbidities (cardiovascular, renal, hepatic) that increase procedural risk.

Responsible follow-up and pharmacovigilance

Suggested checkpoints

• 48–72 hours: review local signs, pain, temperature and early reactions.
• 4–6 weeks: initial clinical and functional assessment; adjust rehabilitation.
• 3 months: compare against baseline; decide on complementary treatments.
• 6–12 months: evaluate maintenance and consolidation of outcomes.

Red flags (seek care immediately)

• Persistent fever ≥ 38.5 °C (101.3 °F).
• Progressive, severe pain or marked functional limitation.
• Notable discharge, redness or heat at the application site.
• Shortness of breath, palpitations or new neurological symptoms.

Recording and reporting

• Document adverse events and outcomes using objective scales.
• Report to the relevant health authority according to local regulations, when applicable.

Regulatory compliance: what patients should know

• Verify that the provider is authorized and the product has quality documentation.
• Request written protocols, chain of custody and a follow-up plan.
• Be cautious of absolute claims or “one-size-fits-all” treatments without supporting evidence.

How we select candidates at Regencord

1. Comprehensive medical evaluation and confirmed diagnosis.
2. Review of indications and exclusions with the patient.
3. Clear information on risks/benefits and therapeutic alternatives.
4. Standardized procedure in a controlled environment.
5. Structured follow-up with objectives and functional metrics.

Frequently asked questions

References and further reading

• Guidelines from scientific societies on clinical translation and safety in cell therapies.
• Local regulatory documents and advanced therapy frameworks.
• Recent systematic reviews and meta-analyses on safety by indication and administration route.