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Skin cells could help heal torn shoulder tendons

NCT ID NCT07219654

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether injections of donated skin cells (TPX-115) can improve shoulder function and reduce pain in people with partial-thickness rotator cuff tears. About 60 adults whose symptoms have lasted over 3 months despite other treatments will receive either the cell therapy or a placebo. The main goal is to measure changes in shoulder function over 24 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 1. Hemoglobin: 12 to 18 g/dL. 2. 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. 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: 1. inflammatory joint disease (eg, septic arthritis, rheumatoid inflammation) 2. 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) 3. autoimmune disease 4. active hepatitis B or C (except for simple carriers and hepatitis B patients with antiviral medications for 6 months before screening) 5. human immunodeficiency virus antibody-positive 6. history of systemic malignancy within the last 5 years 7. coagulopathy 8. genetic disorders affecting fibroblasts or collagen production (eg. achondroplasia, osteogenesis imperfecta) 9. 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 by their participation in the study. * 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. * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • BioSolutions Clinical Research Center

    RECRUITING

    La Mesa, California, 92262, United States

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Sports & Orthopedic Center - Advanced Research

    ACTIVE_NOT_RECRUITING

    Deerfield Beach, Florida, 33064, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.