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IRCT20250823066963N2 IRCT 2025-10-12 Kerman University of Medical Sciences 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 2025-10-23 anticipated 20 Recruiting https://irct.ir/trial/86734 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, eligible patients were randomly assigned to either the intervention group (oral mucosa stem cell therapy combined with standard surgical repair) or the control group (standard surgical repair only) after initial assessment and obtaining written informed consent. Randomization was simple randomization, and the unit of randomization was individual. The random sequence was generated using a random number table in SPSS version 26 by an independent researcher who was not involved in the intervention or outcome assessment. To ensure allocation concealment, the randomization codes were sealed in opaque, sequentially numbered envelopes. Each envelope was opened only at the time of participant enrollment, ensuring that neither the surgeon nor the outcome assessor was aware of the allocation beforehand, Blinding description: A double-blind design was applied in this trial. Participants were unaware of their group assignment (whether they received stem cell injection or not). All patients underwent the same surgical procedure with identical incisions to prevent awareness of treatment differences. Stem cell sampling and preparation of the suspension were performed by an independent laboratory team, separate from the surgical staff. The injection (stem cell suspension or normal saline) was administered by the same surgeon, who was blinded to the content of each coded syringe prepared by the independent team. Nurses and physiotherapists responsible for postoperative care were not informed about group allocation. The evaluator of shoulder function and the data analyst were also blinded to the intervention type to minimize measurement and interpretation bias. Randomization codes were opened only after completion of data collection by the principal investigator. 2 Rotator cuff tear of shoulder. 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 small biopsy (approximately 3×3 millimeters) is obtained from the oral mucosa under local anesthesia. Mesenchymal stem cells are isolated and expanded in a specific culture medium under sterile conditions. During surgical repair, a cell suspension containing approximately one million cells in one milliliter of normal saline is injected at the tendon–bone interface. This procedure is performed during the same surgical session. After surgery, patients are followed according to the standard rehabilitation protocol. Intervention 2: Control group:Patients in this group undergo standard surgical repair of the rotator cuff tendon without any stem cell or additional injection.The surgical procedure involves open or arthroscopic repair of the torn tendon using nonabsorbable sutures at the tendon–bone junction. All surgeries are performed by the same surgeon, and postoperative care and rehabilitation protocols are identical in both groups. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information is available
public Ali Torabi nejad kermani
No.6,2 Sharghi,2 Zafar Street,Kerman Town
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3244 5959 Alitorabinejad99@gmail.com Kerman University of Medical Sciences scientific Amirreza Sadeghi Far
Gharani Street, Shahid Bahonar Hospital
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 bahonarh@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 M75.1 Rotator cuff tear or rupture, not specified as traumatic Treatment - Surgery Treatment - Surgery 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 small biopsy (approximately 3×3 millimeters) is obtained from the oral mucosa under local anesthesia. Mesenchymal stem cells are isolated and expanded in a specific culture medium under sterile conditions. During surgical repair, a cell suspension containing approximately one million cells in one milliliter of normal saline is injected at the tendon–bone interface. This procedure is performed during the same surgical session. After surgery, patients are followed according to the standard rehabilitation protocol. Control group:Patients in this group undergo standard surgical repair of the rotator cuff tendon without any stem cell or additional injection.The surgical procedure involves open or arthroscopic repair of the torn tendon using nonabsorbable sutures at the tendon–bone junction. All surgeries are performed by the same surgeon, and postoperative care and rehabilitation protocols are identical in both groups. 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. Kerman University of Medical Sciences Approved 2025-08-12 Ethics committee of Kerman University of Medical Sciences Beginning of Haft Bagh Alavi Blvd., Kerman University of Medical Sciences Campus Kerman Kerman Iran (Islamic Republic of)