Rotator Cuff TendinopathyEarly Phase 1NCT07320378
Clinical Study on the Safety and Efficacy of Tendon Stem Progenitor Cells Therapy for Rotator Cuff Tears
A Early Phase 1 study testing Stem cell therapy and Conventional rotator cuff repair. in people with Rotator Cuff Tendinopathy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Tendon injury is one of the most common sports injuries, including local tissue degeneration at the tendon insertion site following inflammation caused by long-term joint movement, friction, or strain, as well as acute traumatic tendon tears and defects of varying degrees due to sports. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rotator Cuff Tendinopathy
- What is being tested?
- Stem cell therapy and Conventional rotator cuff repair.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Jan 2029
- Phase
- Early Phase 1
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 70 years, regardless of gender;
- Tear size classified as small (< 1 cm) or medium-sized (1 cm to 3 cm) according to the DeOrio and Cofield classification system;
- Persistent shoulder pain or functional limitations despite at least 3 months of non-surgical treatment, with indications for arthroscopic rotator cuff repair;
- Willing to sign the informed consent form and agree to participate in this study.
Who cannot join
- Tear size classified as large (3 cm to 5 cm) or massive (> 5 cm) according to the DeOrio and Cofield classification, or Patte grade 3 tendon retraction;
- Subscapularis tendon tear;
- Complicated with anterior, posterior, or multidirectional shoulder joint instability;
- Indications for repair of anterior or posterior labral injury;
- Intra-articular injection of hyaluronic acid or corticosteroids within 3 months prior to the planned surgery;
- Comorbidities that contraindicate arthroscopic shoulder surgery;
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- Local (shoulder, abdomen, buttocks) or systemic infection, osteomyelitis, or sepsis;
- Diabetes mellitus, untreated thyroid disease, chronic kidney disease, or rheumatoid arthritis;
- Immunodeficiency;
- Chronic diseases involving coagulation or platelet aggregation, or severe coagulopathy;
- Severe cardiovascular disease;
- Stroke or acute cardiovascular event within 6 months prior to the planned surgery;
- Weight loss > 30 kg for any reason within 12 months, or unexplained weight loss > 10 kg within 12 months;
- Eating disorder or body dysmorphic disorder;
- Alcohol/drug addiction or mental illness that may affect compliance with postoperative protocols;
- Pregnant or lactating women;
- Refusal to sign the informed consent form;
- Other conditions deemed inappropriate by the investigators.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Tendon injury is one of the most common sports injuries, including local tissue degeneration at the tendon insertion site following inflammation caused by long-term joint movement, friction, or strain, as well as acute traumatic tendon tears and defects of varying degrees due to sports. It is a recognized therapeutic challenge in orthopedics and sports medicine. With the increase in people's physical activities and changes in work styles, tendon injuries have become increasingly prevalent, with at least 30 million tendon injury cases annually. Meanwhile, tendon injuries pose a significant threat to the careers of many elite athletes. Currently, clinical treatments for tendon injuries mainly remain at the stages of physical therapy, surgical suture, and transplantation. Although these treatments have certain effects, their efficacy is limited-primarily because adult tendons lack complete regenerative capacity. As a result, the quality of repaired tendons is far inferior to that of normal tendons, making them prone to tendon adhesion, poor structural and mechanical properties, and frequent re-rupture. Even autologous tendon transplantation can only achieve approximately 40% of the mechanical properties of normal tendons, accompanied by excessive scar tissue formation. Current therapeutic and tissue engineering approaches can only partially improve tendon repair quality, failing to induce complete tendon repair and regeneration. Therefore, exploring new and efficient strategies for the treatment and regeneration of tendon injuries is of great significance.
In recent years, cell therapy has brought new opportunities for improving the repair quality of soft tissues such as tendons. Tendon-derived cells are isolated and extracted from tendons. These cells not only possess stem cell characteristics similar to bone marrow mesenchymal stem cells but also highly express tendon-specific genes and proteins. Therefore, this study intends to first culture and expand tendon stem/progenitor cells (TSPCs) to form therapeutic agents, then apply TSPC-enhanced therapy intraoperatively to patients with rotator cuff tendinopathy, and evaluate its clinical safety and efficacy.
- Conditions
- Rotator Cuff Tendinopathy
- Being tested
- Stem cell therapy, Conventional rotator cuff repair.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem cell therapyBiological
For patients in the TSPCs group, after removing the arthroscopic fluid, the prepared TSPCs loaded on a scaffold were injected into the tendon - bone junction and over the repaired tendon using a spinal needle. Fibrin glue (Fibrin Sealant (Human), RAAS) served as the scaffold. The TSPCs suspension was first mixed with thrombin solution at a 3:1 ratio. Then, using the DUPLOJECT syringe support system (Fibrin Sealant (Human), RAAS), 2 ml of cell - thrombin suspension was combined with 2 ml of fibrinogen solution at a 1:1 ratio and applied to the repaired tendon surface. After extracting the arthroscopic fluid, this cell - thrombin - fibrinogen suspension was implanted under arthroscopic guidance. A probe was used to spread and adjust the fibrin glue to cover the repaired tendon - bone junction and tendon surface.
Conventional rotator cuff repair.Procedure or surgery
All procedures were performed under general anesthesia. Patients were in a beach-chair position. After glenohumeral inspection, subacromial decompression was conducted, and acromioplasty was performed. After subacromial decompression, the upper surface of the greater tuberosity was abraded to create a bleeding cancellous bone bed. The footprint of the greater tuberosity was debrided. Rotator cuff repair was performed using a double-row suture bridge technique. For medial-row repair, a hole was punched in the greater tuberosity, and a bioabsorbable suture anchor was inserted. After the medial row was completed, the suture limbs were used to create suture bridges over the tendon. The lateral fixation points were placed, and the suture anchor was used for lateral-row fixation.
| Study group | Role | What they receive |
|---|---|---|
| Conventional surgery group | Active comparator | All procedures were performed under general anesthesia, including subacromial decompression, acromioplasty, and rotator cuff repair using a double-row suture bridge technique. Receives: Procedure: Conventional rotator cuff repair. |
| TSPCs enhanced group | Experimental | For patients in the TSPCs group, after removing the arthroscopic fluid, TSPCs mixed with fibrin glue were applied to the tendon-bone junction and repaired tendon surface under arthroscopic guidance. Receives: Biological: Stem cell therapy; Procedure: Conventional rotator cuff repair. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I：Incidence and severity of cell therapy related adverse events
Incidence and severity of cell therapy related adverse events:Adverse events are defined as abnormal laboratory test results, symptoms or signs, and are graded using the Common Terminology Criteria for Adverse Events (CTCAE). Serious adverse events are defined as any grade 3 or 4 adverse events as specified in the CTCAE.
Measured: In 12 weeks
Phase II：Oxford Shoulder Score (OSS)
OSS is a patient-reported measure used to assess functional limitations following shoulder surgery. It consists of 12 items, each with five response categories, and scores can range from 0 (indicating the worst functional status) to 48 (indicating the best functional status).
Measured: 24 weeks
Secondary outcomes (6)
Constant-Murley Score (CMS)
The CMS provides an assessment of both Individual parameters and clinical symptoms, which is sufficiently sensitive to reveal even small changes in function. The score consists of four domains : pain (15 points), activities of daily living (20 points), movement (40 points), and strength (25 points).
Measured: Baseline,Post-op Week 12,Post-op Week 24,Post-op Week 48
Range of Motion (ROM)
The examiner passively moved the patient's upper extremity to the end range of flexion, abduction, internal rotation, and external rotation, ensuring movements were within the patient's comfort level. Internal and external rotation were measured at 90° of abduction.
Measured: Baseline,Post-op Week 12,Post-op Week 24,Post-op Week 48
Shoulder pain at rest
A Numerical Rating Scale from 0 to 10 with "0" representing no pain and "10" representing the worst pain imaginable in the preceding week.
Measured: Baseline,Post-op Week 1,Post-op Week 4,Post-op Week 8,Post-op Week 12,Post-op Week 24,Post-op Week 48
Work status
Normal duties, restricted duties/hours, not working.
Measured: Baseline,Post-op Week 12,Post-op Week 24,Post-op Week 48
Tendon Integrity Classification on MRI
According to SUGAYA Classification.
Measured: Post-op Week 24, Post-op Week 48
Muscle wasting of rotator cuff on MRI
Measured using Goutallier classification (Stages 0-4).
Measured: Baseline, Post-op Week 24, Post-op Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study startMay 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TendinopathyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In the Phase I of this clinical study, we will design a dose-escalation clinical study to evaluate the maximum tolerated dose (MTD) and safety of tendon stem/progenitor cell (TSPC)-enhanced rotator cuff repair. In the Phase II of the study, we will design a randomized controlled trial (RCT) to assess the efficacy of TSPC-enhanced rotator cuff repair.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 107 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320378
- Sponsor's protocol ID
- 2025-1814
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of Tendon Stem Progenitor Cells Therapy for Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT07320378
- Acronym / sponsor ID
- 2025-1814
- Conditions
- Rotator Cuff Tendinopathy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 107 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 6 Jan 2026 (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.
Tendon injury is one of the most common sports injuries, including local tissue degeneration at the tendon insertion site following inflammation caused by long-term joint movement, friction, or strain, as well as acute traumatic tendon tears and defects of varying degrees due to sports. It is a recognized therapeutic challenge in orthopedics and sports medicine. With the increase in people's physical activities and changes in work styles, tendon injuries have become increasingly prevalent, with at least 30 million tendon injury cases annually. Meanwhile, tendon injuries pose a significant threat to the careers of many elite athletes. Currently, clinical treatments for tendon injuries mainly remain at the stages of physical therapy, surgical suture, and transplantation. Although these treatments have certain effects, their efficacy is limited-primarily because adult tendons lack complete regenerative capacity. As a result, the quality of repaired tendons is far inferior to that of normal tendons, making them prone to tendon adhesion, poor structural and mechanical properties, and frequent re-rupture. Even autologous tendon transplantation can only achieve approximately 40% of the mechanical properties of normal tendons, accompanied by excessive scar tissue formation. Current therapeutic and tissue engineering approaches can only partially improve tendon repair quality, failing to induce complete tendon repair and regeneration. Therefore, exploring new and efficient strategies for the treatment and regeneration of tendon injuries is of great significance.
In recent years, cell therapy has brought new opportunities for improving the repair quality of soft tissues such as tendons. Tendon-derived cells are isolated and extracted from tendons. These cells not only possess stem cell characteristics similar to bone marrow mesenchymal stem cells but also highly express tendon-specific genes and proteins. Therefore, this study intends to first culture and expand tendon stem/progenitor cells (TSPCs) to form therapeutic agents, then apply TSPC-enhanced therapy intraoperatively to patients with rotator cuff tendinopathy, and evaluate its clinical safety and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- In the Phase I of this clinical study, we will design a dose-escalation clinical study to evaluate the maximum tolerated dose (MTD) and safety of tendon stem/progenitor cell (TSPC)-enhanced rotator cuff repair. In the Phase II of the study, we will design a randomized controlled trial (RCT) to assess the efficacy of TSPC-enhanced rotator cuff repair.
| Arm | Type | Receives |
|---|---|---|
| Conventional surgery group | Active comparator | Procedure: Conventional rotator cuff repair.All procedures were performed under general anesthesia, including subacromial decompression, acromioplasty, and rotator cuff repair using a double-row suture bridge technique. |
| TSPCs enhanced group | Experimental | Biological: Stem cell therapy, Procedure: Conventional rotator cuff repair.For patients in the TSPCs group, after removing the arthroscopic fluid, TSPCs mixed with fibrin glue were applied to the tendon-bone junction and repaired tendon surface under arthroscopic guidance. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18 and 70 years, regardless of gender;
- Tear size classified as small (< 1 cm) or medium-sized (1 cm to 3 cm) according to the DeOrio and Cofield classification system;
- Persistent shoulder pain or functional limitations despite at least 3 months of non-surgical treatment, with indications for arthroscopic rotator cuff repair;
- Willing to sign the informed consent form and agree to participate in this study.
Key exclusion criteria (18 listed)
- Tear size classified as large (3 cm to 5 cm) or massive (> 5 cm) according to the DeOrio and Cofield classification, or Patte grade 3 tendon retraction;
- Subscapularis tendon tear;
- Complicated with anterior, posterior, or multidirectional shoulder joint instability;
- Indications for repair of anterior or posterior labral injury;
- Intra-articular injection of hyaluronic acid or corticosteroids within 3 months prior to the planned surgery;
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 |
|---|---|---|
| Stem cell therapyFor patients in the TSPCs group, after removing the arthroscopic fluid, the prepared TSPCs loaded on a scaffold were injected into the tendon - bone junction and over the repaired tendon using a spinal needle. Fibrin glue (Fibrin Sealant (Human), RAAS) served as the scaffold. The TSPCs suspension was first mixed with thrombin solution at a 3:1 ratio. Then, using the DUPLOJECT syringe support system (Fibrin Sealant (Human), RAAS), 2 ml of cell - thrombin suspension was combined with 2 ml of fibrinogen solution at a 1:1 ratio and applied to the repaired tendon surface. After extracting the arthroscopic fluid, this cell - thrombin - fibrinogen suspension was implanted under arthroscopic guidance. A probe was used to spread and adjust the fibrin glue to cover the repaired tendon - bone junction and tendon surface. | Biological | TSPCs enhanced group |
| Conventional rotator cuff repair.All procedures were performed under general anesthesia. Patients were in a beach-chair position. After glenohumeral inspection, subacromial decompression was conducted, and acromioplasty was performed. After subacromial decompression, the upper surface of the greater tuberosity was abraded to create a bleeding cancellous bone bed. The footprint of the greater tuberosity was debrided. Rotator cuff repair was performed using a double-row suture bridge technique. For medial-row repair, a hole was punched in the greater tuberosity, and a bioabsorbable suture anchor was inserted. After the medial row was completed, the suture limbs were used to create suture bridges over the tendon. The lateral fixation points were placed, and the suture anchor was used for lateral-row fixation. | Procedure or surgery | Conventional surgery group, TSPCs enhanced group |
Primary outcome
Phase I：Incidence and severity of cell therapy related adverse events
Time frame: In 12 weeks
Incidence and severity of cell therapy related adverse events:Adverse events are defined as abnormal laboratory test results, symptoms or signs, and are graded using the Common Terminology Criteria for Adverse Events (CTCAE). Serious adverse events are defined as any grade 3 or 4 adverse events as specified in the CTCAE.
Phase II：Oxford Shoulder Score (OSS)
Time frame: 24 weeks
OSS is a patient-reported measure used to assess functional limitations following shoulder surgery. It consists of 12 items, each with five response categories, and scores can range from 0 (indicating the worst functional status) to 48 (indicating the best functional status).
6 secondary outcomes
Constant-Murley Score (CMS)
Time frame: Baseline,Post-op Week 12,Post-op Week 24,Post-op Week 48
Range of Motion (ROM)
Time frame: Baseline,Post-op Week 12,Post-op Week 24,Post-op Week 48
Shoulder pain at rest
Time frame: Baseline,Post-op Week 1,Post-op Week 4,Post-op Week 8,Post-op Week 12,Post-op Week 24,Post-op Week 48
Work status
Time frame: Baseline,Post-op Week 12,Post-op Week 24,Post-op Week 48
Tendon Integrity Classification on MRI
Time frame: Post-op Week 24, Post-op Week 48
Muscle wasting of rotator cuff on MRI
Time frame: Baseline, Post-op Week 24, Post-op Week 48
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 6 Jan 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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Stem cell therapy and Conventional rotator cuff repair. in people with Rotator Cuff Tendinopathy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 4 inclusion and 18 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: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Contact ZeTao Wang (+8613858885932, 843047681@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I：Incidence and severity of cell therapy related adverse events (time frame: In 12 weeks). The study lists 2 primary outcomes in all. 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 6 Jan 2026.