R&D of New Biomedical Technologies

Background

Aging is a comprehensive degenerative process driven by the age-related depletion of quantity and activity in somatic stem cells, accompanied by telomere shortening, declining NAD+ levels, chronic low-grade inflammation, and deterioration of metabolic and immune functions. Currently, no approved drugs exist globally for anti-aging or life extension, and most commercial anti-aging products lack rigorous clinical evidence. This project establishes an innovation consortium with the Institute of Advanced Technology at the Chinese Academy of Sciences to develop autologous hematopoietic stem cell formulations and conduct systematic preclinical studies targeting multi-organ functional decline associated with aging.

R&D Content

1. 1Formulation Process Development：Isolate mononuclear cells from adult peripheral blood and direct them to become clinical-grade autologous hematopoietic stem cells using a small-molecule induction system. Optimize the entire workflow—including induction, expansion, cryopreservation, and thawing—and establish a standardized manufacturing SOP. Complete full quality release testing, including cell phenotyping (e.g., CD34+ and other hematopoietic stem/progenitor markers), karyotype analysis, microbiological testing, and tumorigenicity assessment.
2. 2In Vitro Functional Evaluation：Evaluate the biological effects of secreted factors (e.g., eNAMPT, cytokine profiles); assess anti-inflammatory, antioxidant, and immunomodulatory functions; and evaluate improvements in senescent cells (SASP phenotype).
3. 3Animal model validation：Animal models show a 22.5% increase in life expectancy, 13.5% increase in telomere length, and 33.6% increase in eNAMPT levels. Improvements were observed in physical performance, metabolic homeostasis, liver function, lipid profile, spatial memory, and chronic inflammation, with multiple aging phenotypes reversed. The related paper is in preparation for publication.
4. 4Safety Evaluation：Complete safety assessments for long-term carcinogenicity, immune rejection, and in vivo distribution; monitor animal survival, general condition, and pathological changes in organs.

Current Stage

Preclinical animal study phase (in collaboration with CAS Advanced Institute): Multi-dimensional assessment of aged mice after 6 months of intervention has been completed. Human clinical trials have not yet commenced.

Background

There are no curative drugs for post-stroke sequelae. Thrombolytics have strict time windows, rehabilitation offers only limited symptom relief, and necrotic brain tissue cannot be repaired; allogeneic stem cells carry risks of mismatch and immune rejection. This project aims to develop an autologous neural stem cell therapy for repairing ischemic stroke-related damage.

R&D Content

1. 1Process Optimization：Generate clinical-grade autologous neural stem cells from peripheral blood-derived somatic cells using small-molecule-directed induction; optimize induction and expansion protocols, and determine the optimal cell dosage for administration.
2. 2In Vitro Evaluation：Assess biological activities: detection of neuronal markers, neuroprotection, anti-apoptosis, and angiogenesis promotion.
3. 3Animal model validation：Establish an animal model of cerebral ischemia injury; evaluate the formulation's efficacy, safety, in vivo distribution, and tumorigenicity; monitor motor function and neurological recovery.
4. 4Quality Standards：Establish comprehensive quality testing specifications for the formulation.

Current Stage

Preclinical efficacy and safety evaluation is complete; human trials have not yet been initiated.

Background

Type 2 diabetes lacks a curative therapy to reverse disease progression. Current glucose-lowering drugs primarily manage blood sugar levels but cannot repair damaged pancreatic β cells, leaving patients at risk of long-term complications such as nephropathy and neuropathy. This project develops an autologous pancreatic stem cell therapy to target islet injury and insulin resistance for therapeutic intervention.

R&D Content

1. 1Process Development：Induce autologous pancreatic stem cells from peripheral blood somatic cells, optimize differentiation protocols, and obtain cell preparations with islet-protective functions.
2. 2In vitro functional validation：Evaluate the biological activity of cells in protecting pancreatic β-cells and improving insulin resistance.
3. 3Animal Model Studies：Administer to 2 type diabetes animal models; monitor fasting blood glucose, HbA1c, and insulin levels; assess potential improvement in renal and peripheral tissue complications; complete GLP safety and tumorigenicity evaluations.
4. 4Establish release testing standards for formulations.

Current Stage

Preclinical animal efficacy studies have been conducted; human trials have not yet been initiated.

Background

After a myocardial infarction, necrotic heart muscle transforms into fibrotic scar tissue. Current drugs and stent procedures primarily improve cardiac workload but cannot reverse established scars or regenerate damaged myocardium, leaving limited treatment options for heart failure following old myocardial infarction. This project develops an autologous hematopoietic stem cell therapy to address post-infarction myocardial fibrosis and declining cardiac function.

R&D Content

1. 1Formulation Process：Induce and prepare autologous hematopoietic stem cells from peripheral blood, optimize expansion processes, and determine administration routes and effective cell doses.
2. 2In vitro：Evaluate biological activity in inhibiting fibroblast fibrosis and promoting neovascularization.
3. 3Animal model validation：Administer treatment in a myocardial infarction animal model; assess left ventricular function, myocardial scar area, and viable myocardium percentage; complete safety, in vivo retention, and tumorigenicity evaluations.
4. 4Establish a comprehensive Quality Control SOP.

Current Stage

Preclinical efficacy and safety evaluation in animals has been conducted; human trials have not yet been initiated.

Project Name

Key Technology Development and Clinical Application of FGF21 Combined with β-Klotho Gene-Modified Mesenchymal Stem Cells for Reconstructing Alveolar Epithelial Signaling Axis to Treat Pulmonary Fibrosis

Project Overview

This project utilizes genetically modified mesenchymal stem cells co-expressing FGF21 and soluble β-Klotho to reconstruct the alveolar epithelial signaling axis, focusing on key technology development and clinical application for pulmonary fibrosis therapy.

Current Stage

Preclinical efficacy and safety evaluation in animals has been conducted; human trials have not yet been initiated.

Project Name

Key Technology Development for CAR-NK Cells Targeting CD40 to Regulate Dendritic Cell Metabolic Reprogramming in the Treatment of Systemic Lupus Erythematosus

Project Overview

This project leverages CD40-targeted CAR-NK cell technology to explore novel immunotherapeutic strategies for systemic lupus erythematosus by modulating metabolic reprogramming in dendritic cells.

Current Stage

Preclinical efficacy and safety evaluation in animals has been conducted; human trials have not yet been initiated.