Clinical Research Standards
These standards define how our clinical stem cell research is conducted and how research participants are protected at every stage.
CITI-Certified · FDA IND Oversight · FDA GCP–Aligned · IRB-Approved
CITI-Certified
All investigators involved in our research are CITI-certified (Collaborative Institutional Training Initiative). This certification is required for individuals conducting research involving human subjects in the United States.
Human subjects protection
Research ethics
Informed consent requirements
Participant safety and data integrity
This certification confirms that our research team is properly trained to conduct stem cell research involving human participants in a legal and ethical manner.
FDA GCP–Aligned
Our research is conducted in alignment with FDA Clinical Good Practice (GCP) standards. GCP is an internationally recognized framework that governs how clinical research is designed, conducted, monitored, and documented.
Research participants are protected
Study protocols are followed consistently
Safety events are monitored and addressed
Research data are accurate, reliable, and traceable
These standards exist to safeguard participants and to ensure that research findings are credible and responsibly generated.
FDA IND Oversight
All stem cell research conducted by the Institute is performed under FDA Investigational New Drug (IND) oversight, where required. An IND is the FDA regulatory framework that authorizes the clinical investigation of investigational biologic products in human subjects.
Investigational products meet FDA requirements for manufacturing controls
Product handling and use follow approved protocol conditions
Safety monitoring and adverse event reporting are conducted in accordance with FDA regulations
Clinical research is conducted under defined regulatory supervision
The Institute does not manufacture, market, or sell stem cell products. All investigational stem cell products used in our studies are manufactured by FDA-registered laboratories and are utilized solely within approved research protocols under IND authorization.
Depending on the study design, IND authorization may be held by the Institute or by the FDA-registered manufacturing entity supplying the investigational product. In all cases, the IND governs the approved protocol under which the research is conducted and provides FDA oversight of investigational use.
IRB-Approved
All research conducted by the Institute is reviewed and approved by an Institutional Review Board (IRB). An IRB is an independent committee responsible for protecting the rights, safety, and welfare of research participants.
Reviews study protocols before research begins
Evaluates potential risks and safeguards
Ensures informed consent is clear and complete
Provides ongoing oversight throughout the study
No research begins, is modified, or continues without IRB approval.
Clinical Research Disclaimer
The Institute conducts clinical research only. Investigational stem-cell–based approaches referenced on this page are not FDA-approved and are used solely within approved research protocols. Participation in research is voluntary, and studies are designed to collect data — not to provide approved medical treatment.
The Institute conducts clinical research only and does not market or represent investigational products as approved therapies.