Safety and Preliminary Efficacy of iEVs Injection in Treating Lateral Epicondylitis of Humerus

NCT07111325 | Recruiting Phase 1 DMC

• 1 other identifier: 2024-052
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lateral Epicondylitis

Keywords

lateral epicondylitis; tennis elbow; induced pluripotent stem cell; extracellularvesicles

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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).

  From enrollment to the end of treatment at 12 weeks

• Incidence of adverse events

  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

  From enrollment to the end of treatment at 12 weeks

• Changes in functional outcomes assessed by the Subjective Elbow Value (SEV)

  From enrollment to the end of treatment at 12 weeks

• MRI imaging assessment at 3 months after injection

  From enrollment to the end of treatment at 12 weeks

Study Arms (4)

iEV-high

EXPERIMENTAL

1X10\^10/ml

Biological: iEV; Other: immobilization

iEV-Low

EXPERIMENTAL

1X10\^9/ml

Biological: iEV; Other: immobilization

PRP

ACTIVE COMPARATOR

PRP

Biological: PRP; Other: immobilization

Control

OTHER

Other: immobilization

Interventions

iEV BIOLOGICAL

induced pluripotent stem cell-derived extracellular vesicles

iEV-Low; iEV-high

PRP BIOLOGICAL

PRP injection

PRP

immobilization OTHER

immobilization

Control; PRP; iEV-Low; iEV-high

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai Sixth hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Interventions

Immobilization

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 8, 2025
• Study Start: July 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

CN (1)