TPX-115 for Rotator Cuff Tears

Not yet recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Tego Science, Inc.

Must not be taking: Immunosuppressants

Disqualifiers: Full-thickness tear, Surgeries, Injections, Autoimmune, Others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 56

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TPX-115, a potential drug, to determine if it can help people with Partial-Thickness Rotator Cuff Tears (PTRCT) feel better and move more easily. The study compares different doses of TPX-115 and a placebo, a harmless substance used for comparison, to identify the most effective option. Participants should have experienced PTRCT symptoms like pain or muscle weakness for more than three months without improvement from physical therapy. The goal is to determine if TPX-115 can safely reduce pain and improve shoulder function. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Do I need to stop taking my current medications for the trial?

You will need to stop taking all pain medications for your shoulder, except for a small amount of acetaminophen, at least 72 hours before the trial and throughout the study. The trial does not specify other medication restrictions, but you should discuss your current medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that TPX-115, which uses a type of skin cell, has been tested for safety in treating rotator cuff tears. In earlier studies, most patients tolerated TPX-115 well, and no major safety issues emerged. Some individuals might experience mild side effects, but these are uncommon.

Regarding the cryopreserving hyaluronic acid medium, studies have demonstrated that hyaluronic acid injections are generally safe. They are often used to address joint problems, and most patients do not experience significant side effects.

Both treatments have undergone sufficient study to advance to this phase of the trial, indicating they are considered safe for further testing. However, discussing any concerns with the trial team remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about TPX-115 for rotator cuff tears because it offers a novel approach compared to traditional treatments like physical therapy and corticosteroid injections. Unlike these standard options, TPX-115 works at different dose levels to potentially enhance healing and reduce inflammation more effectively. Additionally, the trial explores the use of cryopreserving hyaluronic acid, which might improve joint lubrication and tissue repair. This new treatment strategy could lead to quicker recovery times and improved outcomes for patients with rotator cuff injuries.

What evidence suggests that this trial's treatments could be effective for rotator cuff tears?

Research has shown that TPX-115, which participants in this trial may receive, may improve shoulder movement in individuals with partial rotator cuff tears. Patients who took TPX-115 scored higher on the Constant-Murley Score, which assesses shoulder movement and pain levels. The American Shoulder and Elbow Surgeons (ASES) score, another measure of shoulder function, also improved after using TPX-115.

Another treatment option in this trial is the cryopreserving hyaluronic acid medium. Studies have found that hyaluronic acid can ease pain and enhance shoulder movement in individuals with rotator cuff tears. In some cases, it has outperformed physical therapy alone, aiding pain relief and movement without causing serious side effects. This suggests that both TPX-115 and hyaluronic acid could benefit shoulder movement and pain relief for rotator cuff injuries. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with Partial-Thickness Rotator Cuff Tear (PTRCT). Specific eligibility details are not provided, but typically participants would need to meet certain health criteria and have a confirmed diagnosis of PTRCT.

Inclusion Criteria

Patients in general good health, with no concomitant conditions or 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 specified laboratory criteria for Hemoglobin, White Blood Cell (WBC) Count, eGFR, ALT, and AST

Patients who are willing and able to give written informed consent for participation in the study

Exclusion Criteria

Patients with clinically significant diseases or medical history of past diseases as specified

Patients whom the principal investigator considers inappropriate for the study due to reasons not listed above

I haven't had shoulder injections in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TPX-115 or placebo to evaluate efficacy and safety in patients with Partial-Thickness Rotator Cuff Tear

24 weeks

Visits at baseline, Week 4, Week 12, and Week 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 weeks

Visits at Week 52

What Are the Treatments Tested in This Trial?

Interventions

• TPX-115

Trial Overview The study tests TPX-115, which consists of allogeneic dermal fibroblasts in a cryopreserving hyaluronic acid medium, against a saline placebo. The main goal is to see if TPX-115 improves shoulder function and pain as measured by the Constant-Murley Score.

How Is the Trial Designed?

Group I: TPX-115 medium dose Experimental Treatment 1 Intervention

Group II: TPX-115 low dose Experimental Treatment 1 Intervention

Group III: TPX-115 high dose Experimental Treatment 1 Intervention

Group IV: Cryopreserving hyaluronic acid medium Experimental Treatment 1 Intervention

Group V: saline Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Tego Science, Inc.

Lead Sponsor

Trials

5

Recruited

390+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07219654

NCT07219654 | Efficacy and Safety Study of TPX-115 on ... The goal of this study is to evaluate the efficacy and safety of allogeneic dermal fibroblasts (TPX-115) compared to placebo in patients ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4762637/

Clinical evidence in the treatment of rotator cuff tears with ... intra-articular injection with HA is effective in reducing pain and improving function in shoulder with rotator cuff tears and without severe adverse reaction.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X23000292

Efficacy of hyaluronic acid in rotator cuff pathology ... It was hypothesized that hyaluronic acid reports better functional outcomes in patients with rotator cuff tendinopathy compared to conservative management, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11907566/

Current evidence on hyaluronic acid injections for rotator cuff ... HA injections were more effective than physical therapy in reducing pain and improving range of motion and function at 3 months, with no ...

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/23259671221115743

Effects of Sodium Hyaluronate in the Treatment of Rotator ... Compared with patients treated with other nonoperative treatments (controls), those treated with SH had significantly improved pain VAS scores at 1 week (WMD = ...

6. mdpi.com mdpi.com/2227-9059/12/4/710

Safety and Efficacy of Wharton's Jelly Connective Tissue ... The overall objective of this study is to evaluate the improvement of patient-reported pain scales after applying Wharton's Jelly (WJ) in rotator cuff defects.

7. journals.lww.com journals.lww.com/md-journal/fulltext/2019/07260/cryopreserved_amniotic_membrane_and_umbilical_cord.60.aspx

Cryopreserved amniotic membrane and umbilical cord... There was also no change in the depth of the rotator cuff tears, however, 2 of the 4 cases with fluid intensity at baseline decreased to PD/T2 at 6 months (Fig.

8. researchgate.net researchgate.net/publication/334700644_Cryopreserved_amniotic_membrane_and_umbilical_cord_particulate_matrix_for_partial_rotator_cuff_tears_A_case_series

Cryopreserved amniotic membrane and umbilical cord ... This study investigated whether intra-articular injection of AM/UC particulate matrix promotes healing of partial rotator cuff tears (RCTs). A ...