Adhesive capsulitis of the shoulder. Calcific tendinitis of shoulder
Conditions
Interventions
Intervention group: single-arm, The intervention under study involves regenerative cell therapy using human umbilical cord–derived mesenchymal stem cells (UC-MSCs).Type and Origin of CellsCell type: H
CD45?, CD34?, CD14? =2%Karyotyping: 46,XX (No chromosomal abnormalities)Primary culture medium: DMEM-LG (Gibco®) supplemented with 10% Fetal Bovine Serum (Gibco®, USA) and 1% Penicillin-Streptomycin.C
Darou Pakhsh®), 2 mL administered prior to cell injection.Monitoring and EvaluationClinical assessments include:VAS score for pain intensity,SPADI index for shoulder function, andRange of Motion (ROM)
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Age 18–75 years Confirmed diagnosis of adhesive capsulitis of the shoulder with documented range-of-motion limitation. Duration of condition = 3 months with insufficient response to standard physiotherapy or medication. Good general health and assessable upper limb function Ability and willingness to comply with rehabilitation program and follow-up visits Provision of written informed consent
Exclusion criteria
Exclusion criteria: History of shoulder surgery or acute fracture within the past 6 months. Severe inflammatory or rheumatic joint diseases affecting the shoulder Active or chronic infection in the shoulder or systemic. Severe systemic disorders (hepatic, renal, cardiac) increasing treatment risk. Allergy or contraindication to the regenerative or cell therapy under study. Participation in other concurrent clinical trials that may affect outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of treatment. Timepoint: 4 weeks after the injection. Method of measurement: Follow-up of clinical symptoms and blood tests.;Treatment response and improvement of shoulder function. Timepoint: 3 month after the injection. Method of measurement: Assessing pain intensity with the VAS index and range of motion with the ROM index. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life of patients. Timepoint: 3 month after the injection. Method of measurement: Standard general health questions (SF-36 or similar).;Stability improves shoulder function. Timepoint: 6 month after the injection. Method of measurement: Long-term follow-up to assess range of motion maintenance and pain reduction. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Javad Verdi
Tehran University of Medical Sciences
Outcome results
None listed