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Adipose tissue derived stem cells in the shoulder rotator cuff tendons tear

Evaluating the effectiveness of autologous adipose tissue derived mesenchymal stem cell in repair of torn shoulder rotator cuff tendons (Phase 2 of a Clinical Trial)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100718004409N15
Enrollment
30
Registered
2024-05-30
Start date
2024-06-21
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Shoulder Tendons Tear. Rotator cuff tear or rupture, not specified as traumatic

Interventions

Intervention 1: Intervention group: It Includes 15 Patients and Fat-derived Stem Cell will be Injected into the Shoulder Tendons of All 15 Patients. Intervention 2: Control group: It includes 15 patie

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to No maximum

Inclusion criteria

Inclusion criteria: More than 30 years of age Chronic shoulder pain during rest or activity Positive specific tests of shoulder(Neer, Hawkins, Lift Off, Empty Can, Resisted Rotation, Drop Arm, External Rotation Lag)) Confirmation of total tear of rotator cuff in shoulder MRI Lack of response to other conservative therapies Absence of indication for surgery or patient dissatisfaction for Surgery

Exclusion criteria

Exclusion criteria: Partial tear of tendons Calcific tendinitis Shoulder capsulitis History of malignancy Contraindication for MRI

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: Before Intervention and 3, 6 and 12 Months After Intervention. Method of measurement: Visual Analog Scale(VAS).;Function of the Shoulder. Timepoint: Before Intervention and 3, 6 and 12 Months After Intervention. Method of measurement: Western Ontario Rotator cuff Index(WORC)Questionnaires and The Disabilities of the Arm, Shoulder, and Hand Outcome Measure (DASH) Questionnaires.

Secondary

MeasureTime frame
Shoulder Joint Range of Motion. Timepoint: Befor Injection and 3, 6 and 12 Months After Injection. Method of measurement: Goniometry.;Rotator cuff Muscles Strength. Timepoint: Befor Injection and 3, 6 and 12 Months After Injection. Method of measurement: Manual strength measurement test.;The number of times patients need to take Analgesics. Timepoint: Befor Injection and 3, 6 and 12 Months After Injection. Method of measurement: Ask the patient.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Parisa Nejati

Iran University of Medical Sciences

parisanejati2@gmail.com+98 21 6435 2446

Outcome results

None listed

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