
A Novel Product for Tendinopathy TreatmentAward last edited on: 2/4/2024
Sponsored Program
STTRAwarding Agency
NIH : NIATotal Award Amount
$2,001,279Award Phase
2Solicitation Topic Code
NIAPrincipal Investigator
Hui B SunCompany Information
New York/R&D/Ctr/Translational Med/Ther
Research Institution
Albert Einstein College of Medicine Inc
Phase I
Contract Number: 1R41AG056246-01A1Start Date: 9/15/2017 Completed: 8/31/2018
Phase I year
2017Phase I Amount
$225,042Public Health Relevance Statement:
Project Narrative Tendinopathy is a common chronic tendon disorder, especially in the aged population, characterized by pain and impaired performance, and currently has no cure or effective treatments. Our preliminary studies show exosomes, extracellular vesicles secreted by mesenchymal stem cells (MSCs) from young donors, when grown on a novel scaffold, exert therapeutic efficacy in healing diseased tendon tissue by carrying specific signaling molecules as active ingredients. The proposed study will determine whether exosomes from MSCs of aged donors grown on this novel scaffold also have therapeutic efficacy in treating tendinopathy.
Project Terms:
achilles tendon; Adipose tissue; Adult; Affect; age group; aged; aging population; Alpha Cell; Animal Model; Animals; Anti-inflammatory; Anti-Inflammatory Agents; Apoptotic; Autologous; base; Behavior; Behavior assessment; Biological Assay; Biological Products; Businesses; cell age; Cells; Characteristics; Chronic; Cicatrix; Clinical; Clinical Trials; Collagen; collagenase; commercialization; Communication; Control Groups; Cultured Cells; Data; design; Disease; Dose; effective therapy; efficacy evaluation; Evaluation; Exhibits; exosome; extracellular vesicles; Frequencies; Gene Expression; Gene Expression Profile; Harvest; healing; Histologic; Histology; Immunohistochemistry; Impairment; improved; in vivo Model; Individual; individual patient; Injectable; Injection of therapeutic agent; Intervention; Investigation; Legal patent; Locomotion; loss of function; mechanical properties; Medical center; Mesenchymal Stem Cells; MicroRNAs; middle age; Modeling; Morphology; nanoscale; New York; novel; Nude Rats; Operative Surgical Procedures; Oryctolagus cuniculus; Outcome; Pain; pain behavior; patellar tendon; Patients; Performance; Phase; Phenotype; Phosphate Buffer; Placebo Control; Placebos; Play; protein biomarkers; Proteins; Protocols documentation; Quality Control; Rattus; repaired; research and development; Role; Rotator Cuff; Rupture; Saline; scaffold; scleraxis; Shapes; Signaling Molecule; Silk; Site; stem; Stem cells; Stress; supraspinatus muscle; Surface; Swelling; Tendinopathy; Tendon Injuries; Tendon structure; Testing; Therapeutic; Therapeutic Effect; Tissues; tool; translational medicine; Travel; treadmill; Treatment Efficacy; two-dimensional; Vesicle
Phase II
Contract Number: 2R44AG056246-02A1Start Date: 9/15/2017 Completed: 5/31/2022
Phase II year
2020(last award dollars: 2021)
Phase II Amount
$1,776,237Public Health Relevance Statement:
Project Narrative Tendinopathy is a common chronic tendon disorder, characterized by pain and impaired performance, and currently has no cure or effective treatments. Our Phase I studies showed that exosomes, nanosized extracellular vesicles secreted by mesenchymal stem cells, when grown on the TenoGen scaffold, a novel 3- dimensional scaffold, exert therapeutic efficacy in healing diseased tendon tissue in rats. The proposed study will test the efficacy and safety of the intended clinical product in an immunodeficient rodent model, and of an analogous product in a rabbit model via autologous and allogeneic treatment.
Project Terms:
3-Dimensional; Address; Adipose tissue; Adverse effects; aged; Allogenic; Animal Model; Animals; Attention; Autologous; base; Biological; Biological Response Modifier Therapy; Businesses; cell age; cell type; Chronic; Cicatrix; Clinical; Clinical Research; Clinical Trials; collagenase; commercial application; commercialization; Cultured Cells; Data; Deterioration; Disease; Dose; effective therapy; efficacy testing; Evaluation; exosome; extracellular vesicles; FDA approved; Fiber; Future; Harvest; healing; Histopathology; Human; immunogenic; Impairment; improved; Inflammatory Infiltrate; Investigation; Investments; Legal patent; mechanical properties; Mesenchymal Stem Cells; Modeling; Morbidity - disease rate; nanosized; New York; novel; Nude Rats; Operative Surgical Procedures; Oryctolagus cuniculus; Outcome; Pain; pain behavior; pain relief; pain symptom; Pathology; Performance; phase 1 study; phase 2 study; pre-clinical; Rattus; repaired; research and development; Rodent Model; Rupture; Safety; scaffold; Schedule; Silk; Site; stem; stem cells; Swelling; Tendinopathy; tendon rupture; Tendon structure; Testing; Therapeutic; Therapeutic Effect; Tissues; Toxic effect; translational medicine; Treatment Efficacy; Treatment Protocols; United States