Effect of Oral Mucosa Stem Cells on Healing and Shoulder Function in Patients with Rotator Cuff Muscle Tear

Comparison of the Effect of Oral Mucosa Stem Cell Therapy and Standard Surgical Repair on Pain Relief, Healing, and Shoulder Function in Patients with Rotator Cuff Muscle Tear: A Randomized Clinical Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250823066963N2

Enrollment

Registered

2025-10-12

Start date

2025-10-23

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator cuff tear of shoulder. Rotator cuff tear or rupture, not specified as traumatic

Interventions

Intervention 1: Intervention group: Patients in this group receive oral mucosa–derived mesenchymal stem cell therapy combined with standard surgical repair of the rotator cuff tendon.Initially, a sma

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 years Written informed consent to participate in the study Full-thickness tear of the supraspinatus tendon Retraction less than 30 mm on MRI No fatty degeneration in the rotator cuff muscle Shoulder pain or weakness for at least 3 months without improvement with non-surgical treatment

Exclusion criteria

Exclusion criteria: Pregnancy Shoulder osteoarthritis Previous shoulder surgery or fracture Psychiatric disorders or fibromyalgia Painful cervical spine pathology Rheumatic diseases Chronic corticosteroid or NSAID use Coagulation disorders or thrombocytopenia Vascular or neurological shoulder lesions Severe uncontrolled comorbid diseases

Design outcomes

Primary

Measure	Time frame
Shoulder pain intensity based on the Visual Analogue Scale. Timepoint: At baseline (before intervention) and at one, two, and three months after surgery. Method of measurement: Pain intensity is measured using a ten-centimeter Visual Analogue Scale where zero indicates no pain and ten indicates the worst imaginable pain.;Shoulder joint range of motion in flexion, extension, abduction, and external rotation. Timepoint: At baseline and three months after surgery. Method of measurement: Range of motion is measured using a goniometer by a trained physiotherapist in standardized positions.;Tendon healing status in follow-up imaging. Timepoint: Three months after surgery. Method of measurement: Tendon healing is evaluated using magnetic resonance imaging (MRI) interpreted by an independent radiologist.	—

Measure

Time frame

Shoulder pain intensity based on the Visual Analogue Scale. Timepoint: At baseline (before intervention) and at one, two, and three months after surgery. Method of measurement: Pain intensity is measured using a ten-centimeter Visual Analogue Scale where zero indicates no pain and ten indicates the worst imaginable pain.;Shoulder joint range of motion in flexion, extension, abduction, and external rotation. Timepoint: At baseline and three months after surgery. Method of measurement: Range of motion is measured using a goniometer by a trained physiotherapist in standardized positions.;Tendon healing status in follow-up imaging. Timepoint: Three months after surgery. Method of measurement: Tendon healing is evaluated using magnetic resonance imaging (MRI) interpreted by an independent radiologist.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Torabi nejad kermani

Kerman University of Medical Sciences

Alitorabinejad99@gmail.com+98 34 3244 5959

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026