Clinical Research Standards
Science & Oversight
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
CITI-Certified Investigators
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.
This certification confirms that our research team is properly trained to conduct stem cell research involving human participants in a legal and ethical manner.
Human subjects protection
Research ethics
Informed consent requirements
Participant safety and data integrity
FDA GCP–Aligned
FDA Clinical Good Practice (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.
These standards exist to safeguard participants and to ensure that research findings are credible and responsibly generated.
Research participants are protected
Study protocols are followed consistently
Safety events are monitored and addressed
Research data are accurate, reliable, and traceable
FDA IND Oversight
FDA Investigational New Drug (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.
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.
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
IRB-Approved
IRB-Approved Clinical Research Only
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.
No research begins, is modified, or continues without IRB approval.
Reviews study protocols before research begins
Evaluates potential risks and safeguards
Ensures informed consent is clear and complete
Provides ongoing oversight throughout the study
The Science
Why Stem Cells
Stem cells are part of the body's natural healing system. Produced in the bone marrow, they circulate throughout the body, seek out injured tissue, and support repair.
As we age, the body produces fewer stem cells, and those cells are increasingly affected by environmental exposure and genetic changes that reduce their effectiveness in repair and healing.
Stem cell therapies are being studied to determine whether this natural mechanism can be supported to restore function and quality of life.
After more than twenty years of clinical research, stem cell therapies have demonstrated a strong safety profile when properly sourced and administered under clinical oversight, with minimal reported side effects and no documented cases of therapy-related cancer.
At the Maule Stem Cell Research Institute, our research studies are designed to explore the body's inherent capacity to heal itself. Through carefully governed clinical investigation, we study whether stem cell therapies can lead to meaningful improvements in function, independence, and daily living for people whose lives are limited by disease or injury.
Clinical Research Disclaimer
Research — Not Treatment
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.