Cellular Science
Biology, methodology, and manufacturing — how regenerative medicine works at the cellular and molecular level. Written for patients seeking understanding and physicians evaluating our protocols.
Core biological concepts underlying every treatment programme.
Stem cells are undifferentiated cells capable of self-renewal and differentiation into specialised cell types. Mesenchymal stem cells (MSCs) — the primary cell type in our protocols — are multipotent adult cells found in bone marrow, adipose tissue, and other sources. Unlike embryonic stem cells, MSCs do not raise ethical concerns and carry no tumorigenic risk. Their therapeutic value lies in three properties: they can migrate to sites of injury, modulate immune responses, and secrete bioactive molecules that support tissue repair.
Cells exchange information through paracrine signalling — the release of proteins, cytokines, growth factors, and extracellular vesicles (exosomes) that influence neighbouring cells. This communication network is how MSCs exert their therapeutic effect: rather than simply replacing damaged tissue, they reprogram the local biological environment by reducing inflammation, promoting blood vessel formation, and activating the body's own repair mechanisms. Understanding this signalling is central to designing effective cellular therapy protocols.
Pharmaceutical drugs are fixed chemical compounds that perform a single predefined function. Cellular therapies are living biological agents that sense and respond to their environment in real time. When MSCs are administered to a patient, they detect inflammatory signals, migrate toward damaged tissue, and release a tailored combination of bioactive factors based on what the local environment requires. This adaptive, multi-target mechanism is why cellular therapy can address complex conditions where single-pathway drugs have limited effect.
Chronic neuroinflammation — sustained immune activation within the central nervous system — is now recognised as a primary driver of disease progression in ALS, multiple sclerosis, Parkinson's, Alzheimer's, and many other conditions. Microglia (the brain's immune cells) become overactivated and damage neurons they are meant to protect. Our therapeutic approach targets this mechanism directly: MSCs and T-regulatory cells suppress pathological immune activation without generalised immunosuppression, restoring a balanced neurological environment.
Definition, manufacturing process, mechanism of action, and clinical rationale for each component of the BioCells protocol.
Multipotent adult stem cells isolated from the patient's own bone marrow (autologous) or, in specific paediatric cases, from screened donor tissue (allogeneic). MSCs express surface markers CD73, CD90, and CD105 and are negative for haematopoietic markers CD34 and CD45 — confirming their identity and purity according to International Society for Cellular Therapy (ISCT) criteria.
Manufacturing & Processing
Bone marrow aspirate (~3-5 ml) is collected under local anaesthesia in a 20-minute bedside procedure. The sample is processed within hours: mononuclear cells are isolated via density gradient centrifugation, seeded in controlled culture conditions, and expanded over 14–21 days. During expansion, cells undergo continuous monitoring for morphology, growth kinetics, and contamination. The final product is tested for viability (>95% required), sterility, endotoxin levels, and immunophenotype before release.
Mechanism of Action
MSCs exert their effect primarily through paracrine signalling — not by differentiating into replacement tissue. They secrete anti-inflammatory cytokines (IL-10, TGF-β), trophic factors (BDNF, GDNF, VEGF), and extracellular vesicles that collectively: (1) suppress pathological immune activation, (2) reduce oxidative stress, (3) promote angiogenesis, (4) support neuronal and glial cell survival, and (5) modulate the local microenvironment to favour endogenous repair. MSCs also home to sites of injury via chemokine gradients (SDF-1/CXCR4 axis).
Clinical Rationale
MSCs are the backbone of our protocols because they address the inflammatory and degenerative mechanisms common to all conditions we treat. Their multi-target mechanism of action — immune modulation, neuroprotection, trophic support — cannot be replicated by a single pharmaceutical agent. MSCs themselves are immunoprivileged — low HLA-I expression, no HLA-II — so rejection risk is minimal in both autologous and allogeneic protocols, with no immunosuppression required.
Multipotent adult stem cells isolated from the patient's own bone marrow (autologous) or, in specific paediatric cases, from screened donor tissue (allogeneic). MSCs express surface markers CD73, CD90, and CD105 and are negative for haematopoietic markers CD34 and CD45 — confirming their identity and purity according to International Society for Cellular Therapy (ISCT) criteria.
Manufacturing & Processing
Bone marrow aspirate (~3-5 ml) is collected under local anaesthesia in a 20-minute bedside procedure. The sample is processed within hours: mononuclear cells are isolated via density gradient centrifugation, seeded in controlled culture conditions, and expanded over 14–21 days. During expansion, cells undergo continuous monitoring for morphology, growth kinetics, and contamination. The final product is tested for viability (>95% required), sterility, endotoxin levels, and immunophenotype before release.
Mechanism of Action
MSCs exert their effect primarily through paracrine signalling — not by differentiating into replacement tissue. They secrete anti-inflammatory cytokines (IL-10, TGF-β), trophic factors (BDNF, GDNF, VEGF), and extracellular vesicles that collectively: (1) suppress pathological immune activation, (2) reduce oxidative stress, (3) promote angiogenesis, (4) support neuronal and glial cell survival, and (5) modulate the local microenvironment to favour endogenous repair. MSCs also home to sites of injury via chemokine gradients (SDF-1/CXCR4 axis).
Clinical Rationale
MSCs are the backbone of our protocols because they address the inflammatory and degenerative mechanisms common to all conditions we treat. Their multi-target mechanism of action — immune modulation, neuroprotection, trophic support — cannot be replicated by a single pharmaceutical agent. MSCs themselves are immunoprivileged — low HLA-I expression, no HLA-II — so rejection risk is minimal in both autologous and allogeneic protocols, with no immunosuppression required.
Laboratory Process
Every therapeutic batch follows a controlled, documented path through our Warsaw laboratory. Seven stages, each with defined quality gates.
Approximately 3-5 ml of bone marrow is collected from the posterior iliac crest under local anaesthesia. The procedure takes ~20 minutes and is performed on-site at our Warsaw clinic. The sample is transferred to the laboratory within minutes.
20 minMononuclear cells are separated from the bone marrow aspirate using density gradient centrifugation. An initial viability count and sterility check are performed. The isolated cell fraction is prepared for culture.
4–6 hoursIsolated cells are seeded in controlled culture conditions — temperature (37°C), CO₂ concentration (5%), humidity, and pharmaceutical-grade growth media. Cells multiply under continuous monitoring: growth kinetics, morphology, and contamination checks at each passage.
14–21 daysEvery batch undergoes a comprehensive testing panel: viability assessment (>95% required), sterility testing (bacterial and fungal), endotoxin screening (LAL test), immunophenotyping (flow cytometry for MSC surface markers), and potency assays to confirm biological activity.
3–5 daysEach of the five therapeutic components is processed through its own dedicated workflow. T-regs are expanded separately. Exosomes are isolated from MSC-conditioned medium. Peptide formulations are prepared based on the patient's metabolic profile. Neurostimulation protocols are programmed.
5–7 daysThe medical board reviews all test results against release criteria. Batch documentation is completed: certificate of analysis, chain-of-custody record, and treatment protocol. Nothing leaves the laboratory without written sign-off from the quality officer and the treating physician.
1 dayTherapeutic components are administered at the clinic under direct medical supervision. The patient is monitored continuously during treatment and receives a medical wearable bracelet for post-treatment data collection. Real-time vital signs and clinical observations are documented.
2–5 daysApproximately 3-5 ml of bone marrow is collected from the posterior iliac crest under local anaesthesia. The procedure takes ~20 minutes and is performed on-site at our Warsaw clinic. The sample is transferred to the laboratory within minutes.
Mononuclear cells are separated from the bone marrow aspirate using density gradient centrifugation. An initial viability count and sterility check are performed. The isolated cell fraction is prepared for culture.
Isolated cells are seeded in controlled culture conditions — temperature (37°C), CO₂ concentration (5%), humidity, and pharmaceutical-grade growth media. Cells multiply under continuous monitoring: growth kinetics, morphology, and contamination checks at each passage.
Every batch undergoes a comprehensive testing panel: viability assessment (>95% required), sterility testing (bacterial and fungal), endotoxin screening (LAL test), immunophenotyping (flow cytometry for MSC surface markers), and potency assays to confirm biological activity.
Each of the five therapeutic components is processed through its own dedicated workflow. T-regs are expanded separately. Exosomes are isolated from MSC-conditioned medium. Peptide formulations are prepared based on the patient's metabolic profile. Neurostimulation protocols are programmed.
The medical board reviews all test results against release criteria. Batch documentation is completed: certificate of analysis, chain-of-custody record, and treatment protocol. Nothing leaves the laboratory without written sign-off from the quality officer and the treating physician.
Therapeutic components are administered at the clinic under direct medical supervision. The patient is monitored continuously during treatment and receives a medical wearable bracelet for post-treatment data collection. Real-time vital signs and clinical observations are documented.
Testing protocols, release criteria, and traceability requirements for every therapeutic batch.
Manufacturing Framework
All cell processing is performed in-house at our certified Warsaw laboratory under EU regulatory standards. No third-party cell banks, no outsourced manufacturing, no off-the-shelf products. Full vertical integration from sample collection to therapeutic administration.
Viability Testing
Cell viability is assessed using Trypan blue exclusion and confirmed by flow cytometry. Minimum release threshold: 95% viable cells. Batches below this threshold are discarded and the process is restarted.
Sterility & Endotoxin
Every batch undergoes 14-day aerobic and anaerobic sterility culture testing (Ph. Eur. 2.6.1) and Limulus Amebocyte Lysate (LAL) endotoxin screening. Endotoxin levels must be below 0.5 EU/ml for release.
Immunophenotyping
MSC identity is confirmed by multi-colour flow cytometry: positive for CD73, CD90, CD105 (>95%); negative for CD34, CD45, CD14, CD19, HLA-DR (<2%). This follows ISCT minimal criteria for MSC characterisation.
Potency Assays
Biological activity is verified through functional assays: immunosuppression assay (MLR inhibition), differentiation capacity (tri-lineage differentiation), and cytokine secretion profiling. Potency data is included in the batch certificate of analysis.
Traceability
Full chain-of-custody documentation for every batch: patient ID, collection date, processing steps, test results, release sign-off, and administration record. All data is maintained in an electronic registry with restricted access, compliant with GDPR and Polish medical record-keeping regulations.
A bone marrow aspirate contains a relatively small number of MSCs — typically 5,000–10,000 per millilitre of marrow. A therapeutic dose requires tens of millions of cells. Expansion in controlled laboratory conditions allows these cells to multiply to therapeutic numbers while maintaining their biological properties. The 14–21 day timeline reflects the time needed for cells to undergo sufficient doublings while preserving viability, potency, and genetic stability. Rushing this process compromises cell quality.
Potency is a measure of biological activity — it answers the question 'will these cells actually work?' For MSCs, potency is assessed through functional assays: can the cells suppress an immune response in vitro (immunosuppression assay)? Can they differentiate into bone, cartilage, and fat tissue (tri-lineage differentiation)? What cytokines are they secreting, and at what levels? A cell batch with high viability but low potency would pass basic quality checks but fail to deliver therapeutic benefit. Our release criteria require both.
Exosomes are nanoscale vesicles (30–150nm) secreted by MSCs. They carry the same bioactive cargo — proteins, mRNA, microRNA — but without being living cells. The key advantages: exosomes can cross the blood-brain barrier (whole MSCs generally cannot), they act faster (minutes vs hours), they can be precisely dosed and stored, and they carry no risk of uncontrolled cell proliferation. The disadvantage: they cannot self-renew or adapt to environmental changes the way living cells can. In our protocols, we use both — cells for sustained, adaptive therapy and exosomes for targeted, rapid molecular delivery.
Whole MSCs have limited ability to cross the intact blood-brain barrier (BBB). However, in neurological conditions, the BBB is often partially compromised by inflammation, which creates entry points for administered cells. Additionally, MSCs can be delivered intrathecally (directly into the spinal fluid) to bypass the BBB entirely when the clinical situation requires it. Exosomes, being nanoscale, can cross the BBB even when it is intact — this is one reason we include them as a separate therapeutic component.
Current research suggests that administered MSCs remain detectable in the body for weeks to months, with their paracrine effects persisting beyond their physical presence. The therapeutic benefit is not solely dependent on cell survival — MSCs reprogram the local immune and regenerative environment, and these changes can persist after the cells themselves have been cleared. This is why patients typically observe continued improvement for 3–6 months after treatment, even though the administered cells are no longer present.
Two patients with the same diagnosis can have fundamentally different disease biology: different inflammatory profiles, different stages of progression, different genetic predispositions, different metabolic states. A standardised protocol treats the diagnosis. A personalised protocol treats the patient's biology. At BioCells Medical, protocol parameters — cell dosage, component combination, delivery route, neurostimulation mapping, peptide selection — are all determined by the individual patient's molecular profiling, immune assessment, and functional status. This is why our five-component approach exists: not every patient needs every component, and the configuration changes based on what the biology requires.
Apply This Science to Your Diagnosis
Each treatment programme is built from these five components, configured for a specific diagnosis. Explore condition-specific protocols or request a personalised evaluation.
