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

NCT07219654 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: TG-TPX-115-24-US-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Partial Thickness Rotator Cuff Tears

Outcome Measures

Primary Outcomes (1)

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

  The CMS is calculated from 0 (worst function) to 100 (best function) points

  Baseline, Week 24

Secondary Outcomes (10)

• Change from baseline in Constant-Murley Score(CMS) at Weeks 4, 12, and 52

  Baseline, Week 4, Week 12, Week 52

• Increase of at least 8 points from baseline in Constant-Murley Score(CMS) at Week 24

  Baseline, Week 24

• Change from baseline in Visual Analogue Scale(VAS) (0 to 10 cm) score for shoulder pain at Weeks 4, 12, 24, and 52

  Baseline, Week 4, Week 12, Week 24, Week 52

• Change from baseline in Range of Motion(ROM) in the affected shoulder at Weeks 4, 12, 24, and 52

  Baseline, Week 4, Week 12, Week 24, Week 52

• Change from baseline in American Shoulder and Elbow Surgeons(ASES) score at Weeks 4, 12, 24, and 52

  Baseline, Week 4, Week 12, Week 24, Week 52

Study Arms (5)

TPX-115 low dose

EXPERIMENTAL

Biological: TPX-115

TPX-115 medium dose

EXPERIMENTAL

Biological: TPX-115

TPX-115 high dose

EXPERIMENTAL

Biological: TPX-115

Cryopreserving hyaluronic acid medium

EXPERIMENTAL

Other: Cryopreserving hyaluronic acid medium

saline

PLACEBO COMPARATOR

Drug: Saline

Interventions

TPX-115 BIOLOGICAL

Single injection of Allogeneic dermal fibroblasts (TPX-115) via ultrasound-guided intratendinous injection

TPX-115 high dose; TPX-115 low dose; TPX-115 medium dose

Cryopreserving hyaluronic acid medium OTHER

Medium included in TPX-115 for cryopreservation

Cryopreserving hyaluronic acid medium

Saline DRUG

Saline

saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged \>= 18 years.
• Patients with PTRCT involving \<= 50% of the tendon thickness based on depth of defect (or Grade I or II on Ellman classification) assessed by MRI within the last 3 months prior to screening and determined by the investigator.
• Patients with clinical symptoms including but not limited to pain, muscle weakness, or limited active range of motion (ROM) of PTRCT persisting for more than 3 months despite conservation treatment.
• Patients who report a usual pain level of \>= 4 on visual analogue scale (VAS) at screening.
• Patients who had, in the opinion of the investigator, at least 1 reasonable physical therapy course and no substantial response within 6 months prior to enrollment.
• Patients who are willing to discontinue all pain medications on the shoulder (except rescue medication of \< 3.25g acetaminophen per day) at least 72 hours prior to screening and throughout the duration of study.
• Patients in general good health, with no concomitant conditions or taking treatments potentially representing confounding factors and interfering with the study treatment or study procedures and their results or putting the patient at a greater risk, as per the investigator's documented clinical judgment.
• Patients who meet the following laboratory criteria, with results within 5% of the specified normal reference ranges:
• Hemoglobin: 12 to 18 g/dL.
• White Blood Cell (WBC) Count: 4.5 to 11.0 x 10\^3/uL.
• Patients with eGFR \> 60 ml/min
• Patients with ALT and AST \< 3xUpper limit of normal
• Patients who are willing and able to give written informed consent for participation in the study.

You may not qualify if:

• Patients with full-thickness rotator cuff tear in the affected shoulder as assessed by MRI.
• Patients with both partial- and full-thickness rotator cuff tear in the affected shoulder.
• Patients who have experienced previous surgeries in the affected shoulder within 12 months prior to enrollment.
• Patients who have received subacromial or intra-articular injection in the affected shoulder within 3 months prior to screening visit.
• Patients who have a history of cell therapy or prolotherapy in the affected shoulder.
• Patients who have received platelet-rich plasma (PRP) injection in the affected shoulder within 6 months prior to screening visit.
• Patients who have received systemic immunosuppressive therapy within 4 weeks prior to screening visit.
• Patients who have any of the following clinically significant diseases at screening or have medical history of past:
• 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

Sponsors & Collaborators

• Tego Science, Inc.: lead

Study Sites (3)

BioSolutions Clinical Research Center

La Mesa, California, 92262, United States

Location

Sports & Orthopedic Center - Advanced Research

Deerfield Beach, Florida, 33064, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: October 22, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: October 23, 2025

Record last verified: 2025-10

Locations

US (3)