Status and phase
Conditions
Treatments
About
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:
Enrollment
Sex
Ages
Volunteers
Inclusion 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 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:
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.
Exclusion criteria
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:
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 effective barrier contraception) during the study period.
Note: Suitable contraceptive methods are condom, sponge, gel, diaphragm for contraception, hormonal contraceptives, intrauterine device, etc. Periodic abstinence (eg, calendar method, ovulation method, symptom body temperature method, post-ovulation method) and restraint are not considered an accepted method of contraception. However, women unable to become pregnant due to menopause (at least 12 months since last menstrual period) can participate in the study with negative pregnancy test results.
Primary purpose
Allocation
Interventional model
Masking
60 participants in 5 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal