All
  • All
  • Insight
  • Research Services
  • Preclinical CRO
  • Animal Resource Bank
CN
中文 English

We offer testing services for stem cell product toxicity, immune adverse reactions, tumorigenicity, and unintended differentiation, as well as in vivo assessments of stem cell survival, distribution, homing, differentiation, tissue integration, disease‑modifying effects, and immunomodulatory activities.

We offer testing services for stem cell product toxicity, immune adverse reactions, tumorigenicity, and unintended differentiation, as well as in vivo assessments of stem cell survival, distribution, homing, differentiation, tissue integration, disease‑modifying effects, and immunomodulatory activities.

Explore more

Preclinical Safety and Efficacy Studies of Stem Cells
Psychiatric & neurological disease models

On this page

Publish an article

View more

Preclinical Safety and Efficacy Studies of Stem Cells

We offer testing services for stem cell product toxicity, immune adverse reactions, tumorigenicity, and unintended differentiation, as well as in vivo assessments of stem cell survival, distribution, homing, differentiation, tissue integration, disease‑modifying effects, and immunomodulatory activities.

 

Preclinical Research on Stem Cell Preparations

 

I. Project Overview

The project adheres to the trial version of the preclinical research guidelines for stem cells, “Guidance on Quality Control and Preclinical Research of Stem Cell Products” (2015), and, in accordance with the “Technical Guidance Principles for the Research and Evaluation of Cell Therapy Products” (2017) and the “Documentation Requirements for the Filing of Clinical Research Projects Involving Stem Cells,” among other relevant documents, it has designed its experimental protocol in alignment with the current edition of the Pharmacopoeia of the People’s Republic of China, thereby providing personalized services.

 

II. Scope of Services

We provide preclinical research services for stem cell preparations, supporting and substantiating the safety and efficacy of therapeutic regimens.

In preclinical study protocols, disease animal models relevant to the intended indication are designed and proposed to generate the information needed for clinical trials, including predictions of the potential therapeutic efficacy, mechanisms of action, adverse reactions, and appropriate routes and doses of stem cell administration or implantation in humans.

Based on appropriate animal models, this research aims to develop and establish robust stem cell labeling techniques and in vivo stem cell tracing methods, enabling comprehensive evaluation of stem cell functions such as in vivo survival, distribution, homing, differentiation, and tissue integration.

Based on comprehensive animal model studies, the safety and biological effects of stem cell preparations should be appropriately evaluated.

 

III. Service Items

Safety assessment: toxicity studies, immune-related adverse reactions, tumorigenicity, and unintended differentiation, among others.

Efficacy assessment: in vivo survival, distribution, homing, differentiation, and tissue integration of stem cells, as well as their functions in disease treatment and immune modulation.