Lateral EpicondylitisPhase 1/2iEVsNCT07111325
Safety and Preliminary Efficacy of iEVs Injection in Treating Lateral Epicondylitis of Humerus
A Phase 1/2 study testing iEV, PRP and immobilization in people with Lateral Epicondylitis, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
Evaluate the safety and preliminary efficacy of human induced pluripotent stem cell-derived extracellular vesicle (iEV) injection in the treatment of lateral epicondylitis of the humerus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- iEV, PRP and immobilization
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 31 Dec 2025
- Phase
- Phase 1/2
- 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
- Diagnosed with lateral epicondylitis by clinical symptom examination and MRI or ultrasound, without obvious tendon tear;
- Unilateral lateral elbow pain lasting for more than 12 weeks;
- Pain is provoked by at least 2 of the following methods, with a pain VAS score exceeding 3: maximum grip strength, palpation of the lateral epicondyle of the elbow and surrounding area, resisted dorsiflexion of the wrist or middle finger, or stretching of the forearm extensor muscles under a pain-free grip state;
- Having received physical therapy or non-steroidal anti-inflammatory drug treatment with poor efficacy;
- Individuals with independent behavioral capacity, who have signed the informed consent form themselves.
Who cannot join
- Complaints of ipsilateral muscle pain caused by other reasons in the past 6 months;
- Presence of ipsilateral neurogenic, inflammatory, or systemic joint diseases;
- A history of previous lateral epicondylitis (LET) surgery in the past 6 months;
- Subjects deemed unsuitable for participating in the trial due to other conditions, as judged by the researcher;
- MRI showing that the injury has involved the lateral collateral ligament, with concurrent cartilage damage.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth hospital
Shanghai, Shanghai Municipality, 200000
Jian Ding, Dr., +86 021 64369181, liuyuanec@163.com
About this study
Official title: A Clinical Trial Study Evaluating the Safety and Preliminary Efficacy of Human Induced Pluripotent Stem Cell-derived Extracellular Vesicles (iEVs) Injection for the Treatment of Lateral Epicondylitis of the Humerus
Evaluate the safety and preliminary efficacy of human induced pluripotent stem cell-derived extracellular vesicle (iEV) injection in the treatment of lateral epicondylitis of the humerus.
Read the detailed description
Lateral epicondylitis refers to pain at the lateral epicondyle of the humerus caused by chronic traumatic tendinopathic changes in the origin and insertion of the common extensor tendon on the lateral side of the elbow joint, which result from long-term and repeated loading.
This randomized controlled study aims to observe whether extracellular vesicles derived from human induced pluripotent stem cells (iEVs) can promote the improvement of inflammatory status in injured extensor tendons and alleviate clinical symptoms. The study design will evaluate the efficacy by assessing changes in patients' pain, grip strength, and elbow joint function after treatment with the injection, and compare the efficacy with that of the control groups.
This is an interventional, single-center clinical study. The study plans to adopt a block randomization method without stratification. A randomization list will be generated separately for each research center by a computer, and participants will be randomly assigned to the experimental group, positive control group, and negative control group. There will be 6-12 cases in the experimental group, and 3-6 cases in each of the two control groups.
- Conditions
- Lateral Epicondylitis
- Being tested
- iEV, PRP, immobilization
- Keywords
- lateral epicondylitis, tennis elbow, induced pluripotent stem cell, extracellularvesicles
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iEVBiological
induced pluripotent stem cell-derived extracellular vesicles
PRPBiological
PRP injection
immobilizationOther
immobilization
| Study group | Role | What they receive |
|---|---|---|
| iEV-high | Experimental | 1X10^10/ml Receives: Biological: iEV; Other: immobilization |
| iEV-Low | Experimental | 1X10^9/ml Receives: Biological: iEV; Other: immobilization |
| PRP | Active comparator | PRP Receives: Biological: PRP; Other: immobilization |
| Control | Other | Not described Receives: Other: immobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess changes in pain levels using a Visual Analogue Scale (VAS)
Assess changes in pain levels using the Visual Analogue Scale (VAS). The scale ranges from 0 (no pain) to 10 (the most severe pain), where a higher score indicates more severe pain (worse outcome) and a lower score indicates less severe pain (better outcome).
Measured: From enrollment to the end of treatment at 12 weeks
Evaluate changes in functional outcomes through patient-rated tennis elbow assessments (PRTEE)
To assess changes in functional outcomes, the Patient-Rated Tennis Elbow Evaluation (PRTEE) is utilized. This scale encompasses 15 items, divided into two dimensions: the pain dimension (5 items) and the function dimension (10 items). It uses a 0-10 scoring system, where a higher total score indicates more severe functional impairment (worse outcome), and a lower total score indicates less severe functional impairment (better outcome).
Measured: From enrollment to the end of treatment at 12 weeks
Assess changes in functional outcomes using the Mayo Elbow Performance Score (MEPS)
To assess changes in elbow function, the Mayo Elbow Performance Score (MEPS) is employed. This scale ranges from 0 to 100, where a higher score indicates better elbow function (better outcome) and a lower score indicates worse elbow function (worse outcome).
Measured: From enrollment to the end of treatment at 12 weeks
Incidence of adverse events
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (3)
Changes in the results of the SF-36 Quality of Life Questionnaire
Measured: From enrollment to the end of treatment at 12 weeks
Changes in functional outcomes assessed by the Subjective Elbow Value (SEV)
Measured: From enrollment to the end of treatment at 12 weeks
MRI imaging assessment at 3 months after injection
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Jul 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Ding, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111325
- Sponsor's protocol ID
- 2024-052
- Acronym
- iEVs
- Status last verified
- Aug 2025
- First submitted
- 31 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Study Evaluating the Safety and Preliminary Efficacy of Human Induced Pluripotent Stem Cell-derived Extracellular Vesicles (iEVs) Injection for the Treatment of Lateral Epicondylitis of the Humerus
- ClinicalTrials.gov ID
- NCT07111325
- Acronym / sponsor ID
- iEVs / 2024-052
- Conditions
- Lateral Epicondylitis
- Keywords
- lateral epicondylitis, tennis elbow, induced pluripotent stem cell, extracellularvesicles
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Aug 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.
Evaluate the safety and preliminary efficacy of human induced pluripotent stem cell-derived extracellular vesicle (iEV) injection in the treatment of lateral epicondylitis of the humerus.
Detailed description
Lateral epicondylitis refers to pain at the lateral epicondyle of the humerus caused by chronic traumatic tendinopathic changes in the origin and insertion of the common extensor tendon on the lateral side of the elbow joint, which result from long-term and repeated loading.
This randomized controlled study aims to observe whether extracellular vesicles derived from human induced pluripotent stem cells (iEVs) can promote the improvement of inflammatory status in injured extensor tendons and alleviate clinical symptoms. The study design will evaluate the efficacy by assessing changes in patients' pain, grip strength, and elbow joint function after treatment with the injection, and compare the efficacy with that of the control groups.
This is an interventional, single-center clinical study. The study plans to adopt a block randomization method without stratification. A randomization list will be generated separately for each research center by a computer, and participants will be randomly assigned to the experimental group, positive control group, and negative control group. There will be 6-12 cases in the experimental group, and 3-6 cases in each of the two control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| iEV-high | Experimental | Biological: iEV, Other: immobilization1X10^10/ml |
| iEV-Low | Experimental | Biological: iEV, Other: immobilization1X10^9/ml |
| PRP | Active comparator | Biological: PRP, Other: immobilizationPRP |
| Control | Other | Other: immobilization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with lateral epicondylitis by clinical symptom examination and MRI or ultrasound, without obvious tendon tear;
- Unilateral lateral elbow pain lasting for more than 12 weeks;
- Pain is provoked by at least 2 of the following methods, with a pain VAS score exceeding 3: maximum grip strength, palpation of the lateral epicondyle of the elbow and surrounding area, resisted dorsiflexion of the wrist or middle finger, or stretching of the forearm extensor muscles under a pain-free grip state;
- Having received physical therapy or non-steroidal anti-inflammatory drug treatment with poor efficacy;
- Individuals with independent behavioral capacity, who have signed the informed consent form themselves.
Key exclusion criteria (5 listed)
- Complaints of ipsilateral muscle pain caused by other reasons in the past 6 months;
- Presence of ipsilateral neurogenic, inflammatory, or systemic joint diseases;
- A history of previous lateral epicondylitis (LET) surgery in the past 6 months;
- Subjects deemed unsuitable for participating in the trial due to other conditions, as judged by the researcher;
- MRI showing that the injury has involved the lateral collateral ligament, with concurrent cartilage damage.
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 |
|---|---|---|
| iEVinduced pluripotent stem cell-derived extracellular vesicles | Biological | iEV-Low, iEV-high |
| PRPPRP injection | Biological | PRP |
| immobilizationimmobilization | Other | Control, PRP, iEV-Low, iEV-high |
Primary outcome
Assess changes in pain levels using a Visual Analogue Scale (VAS)
Time frame: From enrollment to the end of treatment at 12 weeks
Assess changes in pain levels using the Visual Analogue Scale (VAS). The scale ranges from 0 (no pain) to 10 (the most severe pain), where a higher score indicates more severe pain (worse outcome) and a lower score indicates less severe pain (better outcome).
Evaluate changes in functional outcomes through patient-rated tennis elbow assessments (PRTEE)
Time frame: From enrollment to the end of treatment at 12 weeks
To assess changes in functional outcomes, the Patient-Rated Tennis Elbow Evaluation (PRTEE) is utilized. This scale encompasses 15 items, divided into two dimensions: the pain dimension (5 items) and the function dimension (10 items). It uses a 0-10 scoring system, where a higher total score indicates more severe functional impairment (worse outcome), and a lower total score indicates less severe functional impairment (better outcome).
Assess changes in functional outcomes using the Mayo Elbow Performance Score (MEPS)
Time frame: From enrollment to the end of treatment at 12 weeks
To assess changes in elbow function, the Mayo Elbow Performance Score (MEPS) is employed. This scale ranges from 0 to 100, where a higher score indicates better elbow function (better outcome) and a lower score indicates worse elbow function (worse outcome).
Incidence of adverse events
Time frame: From enrollment to the end of treatment at 12 weeks
3 secondary outcomes
Changes in the results of the SF-36 Quality of Life Questionnaire
Time frame: From enrollment to the end of treatment at 12 weeks
Changes in functional outcomes assessed by the Subjective Elbow Value (SEV)
Time frame: From enrollment to the end of treatment at 12 weeks
MRI imaging assessment at 3 months after injection
Time frame: From enrollment to the end of treatment at 12 weeks
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 8 Aug 2025.
Related trials for Lateral Epicondylitis
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing iEV, PRP and immobilization in people with Lateral Epicondylitis, run by Shanghai 6th People's Hospital at 1 site in China.
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 5 inclusion and 5 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 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Assess changes in pain levels using a Visual Analogue Scale (VAS) (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 4 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 8 Aug 2025.