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Tests treatment safety and results for Partial Thickness Rotator Cuff Tears
Official title Efficacy and Safety Study of TPX-115 on Partial-thickness Rotator Cuff Tear
ClinicalTrials.gov ID: NCT07219654
What this study is testing
What is TPX-115?
TPX-115 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for partial thickness rotator cuff tears.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Patients with clinical symptoms including but not limited to pain, muscle weakness, or limited active range of motion (ROM) of PTRCT persisting for...
- 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...
You likely can't join 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.
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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
- genetic disorders affecting fibroblasts or collagen production (eg. achondroplasia, osteogenesis imperfecta)
- other serious diseases (eg. neurological cardiovascular, renal or hepatic disease, uncontrolled diabetes, etc) that, inthe opinion of the investigator, might confound study results or pose additional risk to the patient...
- Female patients who are pregnant or breastfeeding.
- Female patients planning pregnancy during the study period. Women of childbearing potential who do not agree to maintain contraception, or who do not agree to use the appropriate method of contraception (ie, double...
- Patients who have administered other IPs or devices within 4 weeks or 5 half-lives, whichever is greater, prior to the IP administration.
- Patients whom the principal investigator considers inappropriate for the study due to any other reasons than those listed above.
The study team makes the final eligibility decision.
Where it's taking place
- La Mesa, California, United States
- Deerfield Beach, Florida, United States
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Mesa, California, United States; Deerfield Beach, Florida, United States; Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.