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

Conditions

• Partial Thickness Rotator Cuff Tears

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• TPX-115 — BIOLOGICAL
  Single injection of Allogeneic dermal fibroblasts (TPX-115) via ultrasound-guided intratendinous injection
• Cryopreserving hyaluronic acid medium — OTHER
  Medium included in TPX-115 for cryopreservation
• Saline — DRUG
  Saline

Study Details

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

Key Dates

Start date

Nov 30, 2025

Status verified

Oct 2025

Primary completion

May 31, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: TPX-115 low dose
• Experimental: TPX-115 medium dose
• Experimental: TPX-115 high dose
• Experimental: Cryopreserving hyaluronic acid medium
• Placebo Comparator: saline

Primary Outcome Measure

Change from baseline in Constant-Murley Score(CMS) at Week 24 [ Time Frame: Baseline, Week 24 ]

Locations (3)

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