CellPraxis - Advanced Therapies
    Compliance-FirstSince 2007

    Science applied to regenerative medicine
    — with ethics, evidence and governance.

    CellPraxis integrates cell-based platforms and bioactives derived from umbilical cord to develop advanced therapies and translational research programs.

    Informational content. Does not replace professional medical consultation.

    What we do

    Integrated research platforms

    We combine cutting-edge science with regulatory rigor to develop solutions in regenerative medicine.

    Plataformas de pesquisa integradas
    PTAs/ATMPs

    Terapias Celulares e Produtos Biológicos

    Desenvolvimento de PTAs/ATMPs com foco em células mesenquimais (MSCs), CD34+ e derivados de cordão umbilical.

    P&D

    Exossomos/EVs e miRNAs

    Pesquisa e formulações baseadas em vesículas extracelulares e microRNAs para aplicações tópicas e sistêmicas.

    Programas Clínicos e Translacionais
    Translacional

    Programas Clínicos e Translacionais

    Desenho de estudos com endpoints clínicos relevantes, do pré-clínico à validação em humanos.

    GMP

    Qualidade, Rastreabilidade e Compliance

    Padrões CMC/GMP, farmacovigilância e governança em todas as etapas do desenvolvimento.

    Nota: Os programas apresentados estão em diferentes estágios de desenvolvimento. Resultados mencionados referem-se a estudos científicos e não constituem garantia de eficácia clínica.

    Global Context

    Why now?

    The advanced therapies sector is undergoing transformation. Regulatory approvals of CAR-T, gene therapies and cell products demonstrate that science can reach patients — but also teach that rigor, transparency and pharmacovigilance are non-negotiable.

    Accelerated Global Growth

    The cell and gene therapy market is growing exponentially, with new regulatory approvals each year.

    Approved CAR-T and Gene Therapies

    Kymriah, Yescarta, Zynteglo and others demonstrate that advanced therapies can reach the market with robust evidence.

    Pharmacovigilance Lessons

    Market withdrawals (like Alofisel in Europe) reinforce: continuous evidence and robust data are essential.

    Window of Opportunity

    Brazil can position itself strategically in ATMP development with local capacity and global standards.

    2024 Market Value

    $5.6–6.4 Bi
    2024
    $37–94 Bi
    2032-33 Projection
    CAGR >20%
    47%
    North America
    Market Share (2024)
    $12M+
    Cost/year
    Per GMP suite
    "Innovation is fast, but medicine is rigorous: evidence and safety guide the way."
    — CellPraxis guiding principle

    Estimates vary by methodology. Sources: Nova One Advisor, Fortune Business Insights, Grand View Research, ARM.

    People & Governance

    Leadership committed to ethics and excellence

    Our team combines scientific expertise, regulatory experience and commitment to governance in advanced therapies.

    Foto de Luis Eduardo Da Cruz, Research & Development (R&D) Manager da CellPraxis - especialista em medicina regenerativa
    Pharmacist

    Luis Eduardo Da Cruz

    Research & Development (R&D) Manager

    Coordinates R&D strategy, study design, CMC/quality and integration between science and product.

    Foto de Simone Amaral da Silva Cruz, Corporate Efficiency Manager da CellPraxis - especialista em medicina regenerativa
    MBA

    Simone Amaral da Silva Cruz

    Corporate Efficiency Manager

    Leads operational excellence and corporate efficiency — essential for sustainability and scale in biotechnology.

    Foto de Dr. Carolina Cruz, Medical Director da CellPraxis - especialista em medicina regenerativa
    Physician

    Dr. Carolina Cruz

    Medical Director

    Medical supervision of clinical programs, protocol design and interface with investigators.

    "Translating research into product requires balancing innovation, safety, clinical evidence and the patient's real context. The challenge is to advance with scientific rigor, relevant endpoints and transparency — so that regenerative medicine generates concrete health benefits."
    Dra. Valeria Povolotsky, MD PhD - Conselheira científica da CellPraxis especialista em medicina regenerativa
    Dr. Valeria Povolotsky
    Board Member
    1

    Preclinical

    In vitro and animal model studies to assess safety and mechanism of action.

    2

    Phase I

    First human tests focused on safety and tolerability.

    3

    Phase II

    Preliminary efficacy evaluation in specific population with clinical endpoints.

    4

    Phase III

    Large-scale randomized controlled studies to confirm efficacy.

    5

    Real World

    Pharmacovigilance and post-registration evidence in diverse population.

    Clinical Evidence

    How we talk about evidence

    The journey of an advanced therapy — from laboratory to patient — goes through multiple validation stages. Each phase answers different questions about safety, efficacy and applicability.

    At CellPraxis, we are transparent about what stage each program is at. This means not promising results before obtaining them — and communicating both advances and challenges.

    What we evaluate:

    • Level of evidence (RCT, observational studies, case reports)
    • Relevant and validated clinical endpoints
    • Safety profile and adverse events
    • Regulatory status and compliance
    Frequently Asked Questions

    Common questions about regenerative medicine

    Direct, evidence-based answers to the most frequent questions.

    This content is informational and educational. It does not replace consultation with a qualified healthcare professional. For specific questions, consult your doctor.