Why are safety and quality key
in stem cell therapy?
Stem cell therapies are a breakthrough treatment method that offers hope to patients with many challenging conditions. However, the effectiveness and safety of these therapies depend on the highest quality standards at every stage—from cell collection, through preparation, to patient administration. That’s why NovaCell collaborates with the Polish Stem Cell Bank (PBKM), a leader in biobanking in Europe.
What is PBKM and why is it important?
PBKM (Polish Stem Cell Bank) is the largest stem cell bank in Poland and one of the largest in Europe. As part of the international FamiCord group , PBKM has:
- AABB Accreditations (the highest global standard for blood and cell banks)
- ISO 9001:2008 certificates
- Compliance with national and international regulations (GMP, FDA, EMA, ISSCR)
This ensures that the cells used in therapy are obtained, processed and stored according to the most rigorous procedures in the world.
How does the PBKM + NovaCell partnership improve safety and quality?
Certified, thoroughly tested cells
- All stem cell preparations used in NovaCell come exclusively from PBKM.
- Each batch of cells is tested for purity, viability, absence of microbiological contamination and genetic stability.
- PBKM uses manual, precise methods of cell isolation and storage, which allows for obtaining a larger number of living cells than in automated systems.
Advanced monitoring technologies
- NovaCell uses innovative technologies such as non-toxic fluorescent dyes (ChromaLIVE™) and AI-based image analysis (AutoHCS™) to monitor cell quality and differentiation in real time before patient administration.
- This makes each therapy even more controlled and safe.
Individual patient qualification
- Not every patient automatically qualifies for therapy. The final decision is made by the physician after a detailed analysis of the patient's health status, medical history, and test results.
- This approach minimizes the risk of complications and allows for maximum tailoring of therapy to the patient's needs.
Compliance with international standards
- All procedures at NovaCell comply with FDA, EMA, ISSCR guidelines and best practices of clinics in the US and Europe.
- PBKM has accreditations and certificates confirming compliance with the highest quality and safety standards.
Full transparency and patient education
- NovaCell and PBKM focus on clear communication – the patient receives full information about the therapy, its risks and expected effects.
- Each stage of therapy is documented, and the patient has access to test results and cell quality certificates.
Long-term care and monitoring
- Patients are registered in clinical registries and undergo long-term follow-up, which allows for rapid detection and response to possible complications.
- PBKM and NovaCell conduct programs to monitor the safety and quality of therapy.
What does this mean for you as a patient?
- Maximum safety – thanks to rigorous quality control and certified preparations.
- The highest quality of therapy – cells are prepared according to world standards.
- Individual approach – therapy is tailored to your needs and health condition.
- Transparency and support – you receive full information and care at every stage of treatment.
Summary
NovaCell’s partnership with PBKM guarantees that your stem cell therapy is based on state-of-the-art, proven, and safe biobanking solutions . This means you can be confident you’re receiving world-class therapy—without compromising on safety and quality.
