Quality & Compliance: Collection, Processing, and Monitoring Standards at NOVACELL
NOVACELL Medical Center is a modern stem cell therapy clinic that places particular emphasis on patient safety, compliance with international standards, and the highest quality at every stage of treatment. Below are key policies and procedures regarding quality and compliance for stem cell collection, processing, and monitoring at NOVACELL Medical Center.
Cell collection – standards and safety
Allogeneic collection: only certified, thoroughly tested preparations of stem cells from umbilical cords are used, including those from the Polish Stem Cell Bank.
Autologous collection: Stem cells are most often harvested from the patient’s own adipose tissue using minimally invasive liposuction. This method minimizes the risk of immunological rejection and ensures maximum biocompatibility.
Qualified team: The collection is performed by experienced, certified medical personnel, ensuring the patient’s comfort and safety at every stage
Pre-screening: Before collection, a detailed medical interview, a medical history review, and an extensive medical questionnaire are completed. This allows us to exclude high-risk patients and optimize treatment outcomes.
Patient Preparation: The patient receives clear instructions regarding medications, diet, hydration, and any necessary fasting before the procedure. Logistical assistance is provided as needed, for example, for international patients.
Cell processing – advanced technologies and GMP compliance
Immediate transfer to the laboratory: After collection, the material is immediately transferred to a specialized laboratory, minimizing the risk of cell degradation and contamination.
Isolation and purification: Cells are isolated and purified under sterile conditions, in accordance with international guidelines (FDA, EMA, ISSCR) and Good Manufacturing Practice (GMP) standards.
Advanced Quality Monitoring: NovaCell utilizes innovative technologies such as ChromaLIVE ™ (non-toxic fluorescent dyes) and AutoHCS ™ (AI-powered image analysis) to monitor cell quality in real time. Cell purity, viability, and microbial contamination are assessed.
Certified preparations: Only certified, thoroughly tested stem cell preparations are used, including those from the Polish Stem Cell Bank.
Monitoring – quality control, safety and post-hospital care
Batch-by-batch testing: Each batch of cells is tested for purity, viability, and absence of microbial contamination before being administered to a patient.
Registration and tracking: All treatments are registered in clinical registries, which allows for systematic monitoring of effects and possible side effects.
Long-term follow-up: Patients are provided with long-term care and monitoring, which allows for quick detection and response to possible complications and assessment of the effectiveness of therapy.
Documentation and transparency: Every step – from collection, through processing, to cell administration – is documented in detail, ensuring full traceability and compliance with legal requirements.
Processes are designed to protect patient personal and medical information
Compliance with international standards and ethics
Compliance with guidelines: All procedures at NovaCell comply with current legal regulations and international guidelines (FDA, EMA, ISSCR, GMP).
Ethics and transparency: The patient receives clear information about the procedure, risks, benefits and alternatives, and the decision about the therapy is made together with the doctor based on informed consent.
Team of experts: Therapies are conducted by an experienced, multidisciplinary team of doctors, scientists and therapists who constantly improve their qualifications
Summary – Pillars of Quality and Compliance at NovaCell
Download
Autologous, minimally invasive, patient qualification, safety, documentation
Processing
Sterility, advanced QC technologies, GMP, FDA, EMA, ISSCR compliance.
Monitoring
Purity/viability testing, registration, long-term care, data protection
Education & Support
Transparency, informed consent, support at every stage of treatment
Conclusions
NOVACELL The Medical Center implements comprehensive, international quality and compliance standards at every stage of stem cell therapy. Thanks to rigorous quality control, advanced technologies, adherence to GMP guidelines, and an individualized approach to each patient, the clinic ensures maximum safety, effectiveness, and transparency of treatment.
