Scientific Integrity Policy
CELLMEX is committed to evidence-based scientific evaluation, reproducible methodology, transparent communication of uncertainty, responsible research conduct and appropriate separation between scientific conclusions and commercial objectives.
Purpose
CELLMEX is committed to maintaining high standards of scientific integrity in its research, laboratory activities, clinical collaborations, educational materials, scientific communications and development of regenerative medicine technologies.
This policy establishes the principles under which CELLMEX evaluates scientific evidence, develops research programmes, communicates scientific and clinical information, manages uncertainty and protects the integrity of its scientific activities.
Scientific integrity is fundamental to the protection of patients, physicians, investigators, collaborators and the credibility of regenerative and translational medicine as a scientific discipline.
Scope
This policy applies to scientific and medical activities conducted, sponsored, supported, commissioned, communicated or represented by CELLMEX, including laboratory research, translational research, regenerative medicine research, cellular therapy development, mesenchymal stromal cell research, lineage-directed or differentiated cell research, extracellular vesicle and exosome research, secretome and conditioned-media research, immune-cell research, induced pluripotent stem cell research, preclinical studies, clinical research programmes, observational research, investigator-initiated research, scientific collaborations, product characterisation, medical education, website content and technical marketing materials.
It applies to CELLMEX personnel, scientific advisers, investigators, consultants, contractors and collaborators when acting on behalf of or representing CELLMEX.
Core Scientific Principles
Evidence before assertion
Scientific claims should have an appropriate evidentiary basis.
Transparency before promotion
Material limitations, uncertainty and investigational status should be communicated clearly.
Patient safety before commercial opportunity
Scientific and clinical decisions should place patient welfare at the centre of decision-making.
Reproducibility before conclusion
Where practicable, findings should be supported by repeatable methodology and consistent data.
Revision when evidence changes
Scientific positions should evolve when credible new evidence warrants a change.
CELLMEX does not consider scientific hypotheses, laboratory findings, biological plausibility, animal studies, preliminary clinical observations or early-stage clinical research to constitute proof of clinical efficacy unless supported by an appropriate body of clinical evidence.
Evidence-Based Scientific Evaluation
CELLMEX seeks to base scientific and clinical positions upon the best reasonably available evidence. Sources may include peer-reviewed literature, systematic reviews, meta-analyses, controlled clinical studies, prospective studies, observational data, preclinical studies, laboratory characterisation data, mechanism studies, recognised scientific standards, regulatory guidance and consensus statements.
Different categories of evidence carry different levels of scientific weight. Mechanistic plausibility alone should not be presented as equivalent to demonstrated clinical benefit. Laboratory evidence demonstrating a biological effect does not necessarily establish that the same effect will produce a clinically meaningful therapeutic outcome in patients.
Established, Emerging and Investigational Science
Established Clinical Evidence
Scientific or medical interventions supported by sufficient clinical evidence and, where applicable, appropriate regulatory authorisation.
Emerging Scientific Evidence
Technologies or interventions supported by developing scientific evidence for which the clinical evidence remains incomplete.
Translational Research
Scientific work intended to translate laboratory discoveries into potential clinical applications.
Investigational Technologies
Products, procedures, biological materials or therapeutic strategies that remain under scientific or clinical investigation.
Experimental Research
Early-stage scientific work for which safety, efficacy, optimal dosing, administration methodology or clinical utility may not yet have been established.
CELLMEX communications should not intentionally blur these distinctions.
Regenerative Medicine and Scientific Uncertainty
Regenerative medicine is a rapidly developing scientific field. Research involving stem cells, mesenchymal stromal cells, differentiated cell populations, extracellular vesicles, exosomes, secretomes, immune cells, induced pluripotent stem cells and related biological technologies continues to evolve.
- Biological activity does not automatically establish therapeutic efficacy.
- In-vitro findings may not predict clinical outcomes.
- Animal studies may not translate directly to human treatment.
- Early clinical observations require confirmation.
- Small patient cohorts may not establish generalisable conclusions.
- Long-term safety information may remain incomplete for emerging technologies.
- Manufacturing methodology may materially influence biological characteristics.
- Cell source, donor characteristics, passage number, culture conditions, purification methods, storage conditions, administration route and dose may influence biological behaviour and clinical outcomes.
CELLMEX therefore seeks to avoid overstating the maturity of developing scientific technologies.
Scientific Claims and Clinical Outcomes
Any scientific or clinical claim made by CELLMEX should have a reasonable evidentiary basis. Where appropriate, communications should identify whether supporting evidence derives from laboratory research, preclinical research, published human clinical research, CELLMEX observational experience, independent research, external collaborators or peer-reviewed literature.
Potential therapeutic mechanisms should not automatically be interpreted as proven clinical efficacy. Qualifying terms such as may, potential, investigational, under evaluation, associated with, preclinical evidence suggests and research indicates should be used where scientifically appropriate.
Research Methodology and Conduct
Where CELLMEX conducts or supports scientific research, methodology should be designed to produce interpretable and scientifically credible information. Depending upon the programme, appropriate considerations may include clearly defined objectives, predefined protocols, inclusion and exclusion criteria, controls, endpoints, analytical methods, statistical methodology, sample traceability, chain of custody, laboratory controls, quality documentation, reproducibility, data retention and independent review where appropriate.
Research methodology should be proportionate to the scientific question being investigated.
Reproducibility, Characterisation and Batch Consistency
Biological products may demonstrate natural variability. Nevertheless, CELLMEX considers reproducibility and manufacturing consistency essential scientific objectives.
Where applicable, laboratory programmes may evaluate cell identity, viability, phenotype, sterility, endotoxin, mycoplasma, cell count, population characteristics, passage number, culture conditions, potency-related characteristics, extracellular vesicle concentration, particle-size distribution, protein concentration, biomarker expression, product purity, stability, storage conditions and release specifications.
The specific analytical framework depends upon the biological material, process and intended research or clinical application.
Laboratory and Research Data Integrity
Scientific conclusions depend upon reliable data. CELLMEX expects laboratory and research data to be recorded, maintained, reviewed and reported accurately.
Scientific records must not be intentionally fabricated, falsified, selectively altered, manipulated, misrepresented or destroyed for the purpose of concealing scientific information. Material deviations, anomalous findings and unexpected results should be documented and evaluated appropriately.
Unfavourable findings should not be intentionally suppressed solely because they are commercially inconvenient.
Negative and Inconclusive Results
Scientific integrity requires consideration of negative as well as positive results. Experiments may fail, hypotheses may not be supported, biological products may not demonstrate expected activity, clinical observations may be inconclusive and research programmes may require modification or discontinuation.
Negative or inconclusive findings are scientifically valuable and should be considered when evaluating future research.
Scientific Independence and Conflicts of Interest
CELLMEX seeks to maintain appropriate separation between scientific evaluation and commercial objectives. Commercial interest should not determine scientific conclusions.
Scientists, physicians, researchers and technical personnel should be able to identify legitimate scientific concerns without inappropriate pressure to alter scientific interpretation.
Personnel, investigators, advisers and collaborators should disclose material conflicts of interest that could reasonably influence scientific judgement, including financial relationships, consulting arrangements, ownership interests, intellectual-property rights, research sponsorship, commercial partnerships and investigator compensation. A conflict does not necessarily invalidate scientific work, but material conflicts should be identified and managed.
Scientific Publications and Authorship
CELLMEX supports responsible publication and dissemination of scientifically meaningful findings. Publications associated with CELLMEX should, where appropriate, accurately describe methodology, report relevant results, disclose material limitations, identify conflicts of interest and research funding, avoid inappropriate manipulation of data, respect accepted authorship standards, acknowledge contributors and reference relevant scientific literature.
Authorship should reflect meaningful scientific contribution.
Research Collaborations
CELLMEX may collaborate with universities, research institutions, hospitals, physicians, biotechnology companies, pharmaceutical organisations, contract laboratories, independent scientists and regulatory specialists.
The existence of a collaboration does not imply that a collaborating institution endorses every CELLMEX activity, product, service or statement unless such endorsement is expressly documented.
Collaborative research should maintain appropriate scientific independence and clearly defined responsibilities.
Ethical Research Conduct and Human Participants
Research involving human participants should be conducted according to applicable ethical, medical and regulatory requirements. Depending upon the jurisdiction and nature of the research, this may include independent ethics committee or institutional review board review, informed consent, protection of patient privacy, protocol approval, appropriate regulatory authorisation, adverse-event monitoring and data-protection procedures.
Research involving human biological materials should similarly respect applicable ethical and regulatory requirements.
Patient Informed Consent
Where investigational or emerging regenerative medicine technologies are administered within an appropriate clinical or research context, patients should receive information sufficient to understand the nature of the intervention.
Where applicable, informed consent should address the nature of the biological product or procedure, known or reasonably foreseeable risks, potential benefits, scientific uncertainty, alternative treatment options, investigational status, follow-up requirements and limitations of available clinical evidence.
Consent should not be based upon misleading representations of scientific certainty.
Patient Testimonials and Anecdotal Evidence
Individual patient experiences may provide useful qualitative information but do not constitute controlled scientific evidence. Testimonials may be influenced by individual biological variation, concomitant therapy, placebo effects, natural disease progression, lifestyle changes, differences in diagnosis and differences in treatment protocols.
Patient testimonials should therefore not be represented as proof that another patient will experience the same outcome.
Use of External Scientific Literature
CELLMEX may reference external scientific publications for educational purposes. Reference to a publication does not necessarily mean CELLMEX conducted the research, the authors endorse CELLMEX, the publication evaluated a CELLMEX product, the findings apply directly to every CELLMEX programme or the findings establish clinical efficacy.
Literature should be interpreted within the context of the study population, methodology, limitations, intervention studied and quality of evidence.
Scientific and Website Communications
Scientific information published or communicated by CELLMEX should be factually supportable, appropriately contextualised, consistent with available evidence, appropriately qualified, current to the extent reasonably practicable, free from intentional scientific exaggeration, and clear regarding material limitations and investigational status.
Website content may describe biological mechanisms, research areas, laboratory technologies, translational research, emerging therapeutic concepts and published scientific findings. Such content should not automatically be interpreted as a representation that every described technology is commercially available, clinically validated, medically indicated or authorised by regulatory authorities in every jurisdiction.
Medical, Scientific and Regulatory Review
Where appropriate, substantive scientific and medical content published by CELLMEX should undergo internal review by qualified personnel. Review may include scientific, medical, regulatory, quality and legal review where appropriate.
The purpose is to reduce factual errors, unsupported claims, outdated information and potentially misleading interpretations.
Corrections and Scientific Updates
Scientific knowledge changes. CELLMEX may revise website materials, publications, protocols, educational content and scientific positions when new evidence becomes available.
Where a material scientific error is identified, reasonable efforts should be made to correct it. The willingness to revise conclusions when evidence changes is a fundamental component of scientific integrity.
Artificial Intelligence and Scientific Content
Artificial intelligence and computational tools may be used to assist with literature organisation, data analysis, technical drafting, scientific information retrieval and research administration.
AI-generated scientific information should not automatically be regarded as verified scientific evidence. Material scientific conclusions should be subject to appropriate human review and verification.
Regulatory Context
Regenerative medicine is regulated differently across jurisdictions. Scientific development of a technology does not by itself establish regulatory authorisation.
CELLMEX seeks to distinguish between scientific research, laboratory development, clinical investigation, medical practice, regulatory approval and commercial distribution authorisation.
Where applicable, products or procedures may be subject to requirements imposed by competent authorities, including COFEPRIS in Mexico and other national regulatory authorities. Regulatory status may vary by product, indication, jurisdiction, manufacturing method and intended use.
Research Information Versus Medical Advice
Scientific information published by CELLMEX should not be considered a substitute for individual medical evaluation. Treatment decisions require consideration of diagnosis, disease severity, medical history, current medications, laboratory findings, imaging, comorbidities, existing treatment alternatives and risk-benefit considerations.
Clinical decisions should therefore be made by appropriately qualified healthcare professionals.
Protection of Scientific Personnel
CELLMEX supports an environment in which personnel may raise legitimate concerns regarding data integrity, patient safety, protocol deviations, laboratory quality, research ethics, scientific misconduct and unsupported scientific claims.
Good-faith scientific concerns should be reviewed objectively.
Scientific Misconduct
Scientific misconduct is inconsistent with CELLMEX policy. Examples may include fabrication of data, falsification of results, material manipulation of scientific records, plagiarism, deliberate misrepresentation of findings, intentional concealment of significant safety information, misrepresentation of regulatory status, and improper manipulation of images or analytical results.
Allegations of material scientific misconduct should be evaluated through an appropriate internal review process.
Continuous Scientific Review and Governance
CELLMEX considers scientific integrity an ongoing process. Scientific programmes should be periodically reassessed in light of new publications, clinical evidence, regulatory developments, safety information, improved analytical methods, manufacturing developments and evolving scientific standards.
Research programmes may be modified, expanded, suspended or discontinued when justified by emerging evidence.
Our Scientific Commitment
CELLMEX seeks to contribute responsibly to the advancement of regenerative and translational medicine while maintaining a clear distinction between scientific possibility, investigational development and clinically supportable conclusions.
Contact Regarding Scientific Integrity
Questions concerning CELLMEX scientific policies, research methodology, scientific publications or research collaborations may be directed to:
CELLMEX
Scientific & Clinical Research Division
Marina Vallarta
Puerto Vallarta, Jalisco, Mexico
Email: info@cellmex.com
Telephone: +52 322 308 0021
Scientific Information Notice
Information concerning cellular therapies, extracellular vesicles, exosomes, secretomes, differentiated cells, immune-cell technologies, induced pluripotent stem cells and other regenerative technologies may include discussion of investigational, emerging, preclinical or translational research.
References to biological mechanisms or published scientific findings should not be interpreted as guarantees of clinical effectiveness, regulatory approval or suitability for any particular patient. Individual clinical decisions require evaluation by a qualified healthcare professional and must comply with applicable medical and regulatory requirements.