Development pipeline

Every phase, its gate, and what has to be true before we move

Cytosomatic Labs is a preclinical research organization. This page states where each programme actually sits, what work is underway, and the evidence required to advance — including the phases we have not reached.

Researcher loading samples into an analytical instrument, viewed from behind

Pipeline tracking

Where each programme sits today

Progression runs left to right, from discovery through translational readiness. A bar stops at the last phase whose gate condition is documented.

Programme progression across preclinical development phases
ProgrammeP0P1P2P3P4
Neural cell therapyEngineered neural and neuroimmune constructsReached Assay developmentAssay development
NeurodiagnosticsMulti-parameter cytometry and transcriptional panelsReached Assay developmentAssay development
NeurorestorationFunctional recovery in ex vivo neural modelsReached DiscoveryDiscovery

Phase gates

A programme only advances when its gate condition is documented. No phase is skipped, and no phase is described as complete before its record supports it.

  1. P0Active

    Discovery

    Define the mechanism a programme is meant to correct, in human tissue, before any construct is designed.

    Duration
    Continuous
    Status
    Active

    Work in this phase

    • Literature and mechanism review with clinical advisors
    • Target selection in donor-derived neural and neuroimmune cells
    • Feasibility scoring against assay, cost and ethics constraints

    Gate to advance: A written mechanism hypothesis with a measurable readout and a named failure condition.

  2. P1Active

    Assay development

    Build the measurement before the intervention, so a result cannot be an artefact of the method.

    Duration
    6–12 months
    Status
    Active

    Work in this phase

    • Multi-parameter cytometry and transcriptional panel design
    • Reference range establishment across well-phenotyped cohorts
    • Inter-operator and inter-run reproducibility records

    Gate to advance: Assay reproducibility documented across operators, runs and donor material.

  3. P2Next

    Construct validation

    Compare engineered neural cell-therapy constructs and delivery chemistries head to head in primary human cells.

    Duration
    12–18 months
    Status
    Next

    Work in this phase

    • Transduction and vector-free delivery benchmarking
    • Safety-switch and cytokine-release characterisation
    • Negative and null results recorded in the internal validation record

    Gate to advance: A lead construct with a reproducible mechanistic effect and a characterised safety profile.

  4. P3Planned

    Functional restoration

    Show restored neural function — not restored cell counts — in ex vivo and co-culture models.

    Duration
    18 months
    Status
    Planned

    Work in this phase

    • Ex vivo expansion and differentiation protocol work
    • Electrophysiological and network-level functional readouts
    • Durability and neuroinflammatory risk modelling

    Gate to advance: Functional recovery sustained beyond the acute window, with risk modelling attached.

  5. P4Planned

    Translational readiness

    Prepare IND-enabling study design with external clinical and regulatory review.

    Duration
    Subject to P3
    Status
    Planned

    Work in this phase

    • IND-enabling study design with clinical advisors
    • Quality system and documentation review
    • Independent methodological critique before commitment

    Gate to advance: External advisory sign-off. No clinical activity occurs before this gate is cleared.

Scope of this pipeline

All programmes described here are preclinical. Cytosomatic Labs does not treat patients, run clinical trials, sell products or provide medical advice. Nothing on this page should be interpreted as a claim of clinical efficacy or safety in humans.

Reviewing a phase with us

Academic groups, clinical investigators and translational funds can request the underlying method records for any active phase.