Not Yet RecruitingPhase 2

Efficacy and Safety Study of TPX-115 on Partial-thickness Rotator Cuff Tear

United States60 participantsStarted 2025-11

Plain-language summary

The goal of this study is to evaluate the efficacy and safety of allogeneic dermal fibroblasts (TPX-115) compared to placebo in patients with Partial-Thickness Rotator Cuff Tear(PTRCT). Primary endpoint is to evaluate the efficacy of TPX-115 compared to placebo, as measured by improvement in the Constant-Murley Score (CMS) in patients with PTRCT. Secondary endpoints are: * To evaluate functional (including shoulder pain) and structural improvements in the affected shoulder after administration of TPX-115 compared to placebo in patients with PTRCT * To evaluate the safety and tolerability of TPX-115 in patients with PTRCT * To assess the immunogenicity of TPX-115

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Hemoglobin: 12 to 18 g/dL.
✓. White Blood Cell (WBC) Count: 4.5 to 11.0 x 10\^3/uL.

Exclusion criteria

✕. inflammatory joint disease (eg, septic arthritis, rheumatoid inflammation)
✕. other shoulder disease, in the affected shoulder, that may cause shoulder pain or functional disorder (eg, arthritis, cervical spine disorders, subacromial pathological morphology leading to impingement syndrome)
✕. autoimmune disease
✕. active hepatitis B or C (except for simple carriers and hepatitis B patients with antiviral medications for 6 months before screening)
✕. human immunodeficiency virus antibody-positive
✕. history of systemic malignancy within the last 5 years
✕. coagulopathy
✕. genetic disorders affecting fibroblasts or collagen production (eg. achondroplasia, osteogenesis imperfecta)

What they're measuring

Change from baseline in Constant-Murley Score(CMS) at Week 24

Timeframe: Baseline, Week 24

Trial details

NCT IDNCT07219654

SponsorTego Science, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05

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