Partial Thickness Rotator Cuff TearsPhase 2NCT07219654
Efficacy and Safety Study of TPX-115 on Partial-thickness Rotator Cuff Tear
A Phase 2 study testing TPX-115, Cryopreserving hyaluronic acid medium and Saline in people with Partial Thickness Rotator Cuff Tears, run by Tego Science, Inc. at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Thickness Rotator Cuff Tears
- What is being tested?
- TPX-115, Cryopreserving hyaluronic acid medium and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Jun 2026to Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 2 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Nikhil Verma, MD, 312-805-8456, Nikhil.verma@rushortho.com
- Active, not recruiting
Sports & Orthopedic Center - Advanced Research
Deerfield Beach, Florida, 33064
- Recruiting
BioSolutions Clinical Research Center
La Mesa, California, 92262
Peter Hanson, MD, 619-637-0770, drhanson@biosolutionsresearch.com
About this study
Official title: A Phase 2, Double-blinded, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Allogeneic Dermal Fibroblasts (TPX-115) in Patients With Partial-thickness Rotator Cuff Tear
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
- Being tested
- TPX-115, Cryopreserving hyaluronic acid medium, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPX-115Biological
Single injection of Allogeneic dermal fibroblasts (TPX-115) via ultrasound-guided intratendinous injection
Cryopreserving hyaluronic acid mediumOther
Medium included in TPX-115 for cryopreservation
SalineDrug
Saline
| Study group | Role | What they receive |
|---|---|---|
| TPX-115 low dose | Experimental | Not described Receives: Biological: TPX-115 |
| TPX-115 medium dose | Experimental | Not described Receives: Biological: TPX-115 |
| TPX-115 high dose | Experimental | Not described Receives: Biological: TPX-115 |
| Cryopreserving hyaluronic acid medium | Experimental | Not described Receives: Other: Cryopreserving hyaluronic acid medium |
| saline | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Constant-Murley Score(CMS) at Week 24
The CMS is calculated from 0 (worst function) to 100 (best function) points
Measured: Baseline, Week 24
Secondary outcomes (10)
Change from baseline in Constant-Murley Score(CMS) at Weeks 4, 12, and 52
The CMS is calculated from 0 (worst function) to 100 (best function) points
Measured: Baseline, Week 4, Week 12, Week 52
Increase of at least 8 points from baseline in Constant-Murley Score(CMS) at Week 24
The CMS is calculated from 0 (worst function) to 100 (best function) points
Measured: 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
The VAS is a horizontal line, 10 cm in length, with anchor statements on the left (0 cm; meaning 'no pain') and on the right (10cm; meaning 'extreme pain')
Measured: 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
Measured: 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
The ASES score is calculated from zero (worst) to 100 (best) points
Measured: Baseline, Week 4, Week 12, Week 24, Week 52
Change from baseline in Simple Shoulder Test at Weeks 4, 12, 24, and 52
Measured: Baseline, Week 4, Week 12, Week 24, Week 52
Change from baseline in tear size (mm) on MRI at Week 52
Measured: Baseline, Week 52
Change from baseline in tendon thickness (mm) on MRI at Week 52
Measured: Baseline, Week 52
Change from baseline in tear/footprint (%p) on MRI at Week 52
Measured: Baseline, Week 52
Change from baseline in tendinosis on MRI at Week 52
The grade of tendinosis is assessed from zero (normal) to 3 (marked) by a central reader only (independent evaluator).
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2025
- Study start9 Jun 2026
- Primary completionMay 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial Thickness Rotator Cuff TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tego Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219654
- Sponsor's protocol ID
- TG-TPX-115-24-US-01
- Status last verified
- Jun 2026
- First submitted
- 20 Oct 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-blinded, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Allogeneic Dermal Fibroblasts (TPX-115) in Patients With Partial-thickness Rotator Cuff Tear
- ClinicalTrials.gov ID
- NCT07219654
- Acronym / sponsor ID
- TG-TPX-115-24-US-01
- Conditions
- Partial Thickness Rotator Cuff Tears
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tego Science, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 22 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPX-115Single injection of Allogeneic dermal fibroblasts (TPX-115) via ultrasound-guided intratendinous injection | Biological | TPX-115 high dose, TPX-115 low dose, TPX-115 medium dose |
| Cryopreserving hyaluronic acid mediumMedium included in TPX-115 for cryopreservation | Other | Cryopreserving hyaluronic acid medium |
| SalineSaline | Drug | saline |
Primary outcome
Change from baseline in Constant-Murley Score(CMS) at Week 24
Time frame: Baseline, Week 24
The CMS is calculated from 0 (worst function) to 100 (best function) points
10 secondary outcomes
Change from baseline in Constant-Murley Score(CMS) at Weeks 4, 12, and 52
Time frame: Baseline, Week 4, Week 12, Week 52
Increase of at least 8 points from baseline in Constant-Murley Score(CMS) at Week 24
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 4, Week 12, Week 24, Week 52
Change from baseline in Simple Shoulder Test at Weeks 4, 12, 24, and 52
Time frame: Baseline, Week 4, Week 12, Week 24, Week 52
Change from baseline in tear size (mm) on MRI at Week 52
Time frame: Baseline, Week 52
Change from baseline in tendon thickness (mm) on MRI at Week 52
Time frame: Baseline, Week 52
Change from baseline in tear/footprint (%p) on MRI at Week 52
Time frame: Baseline, Week 52
Change from baseline in tendinosis on MRI at Week 52
Time frame: Baseline, Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BioSolutions Clinical Research Center
La Mesa, United States
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TPX-115, Cryopreserving hyaluronic acid medium and Saline in people with Partial Thickness Rotator Cuff Tears, run by Tego Science, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Constant-Murley Score(CMS) at Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.