Umbilical Cord-derived Mesenchymal Stem Cell Injectables for the Regeneration of Partial-thickness Rotator Cuff Tears
A Multi-center Study on Umbilical Cord-derived Mesenchymal Stem Cell Injectables for the Regeneration of Partial-thickness Rotator Cuff Tears
The purpose of this study is to evaluate umbilical cord-derived mesenchymal stem cell injectables for the regeneration of partial-thickness rotator cuff tears
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Kyoung Hwan Koh
- Telefonnummer: +82-2-3010-3530
- E-post: osdoc.koh@gmail.com
Studiesteder
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Seoul
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Seoul, Seoul, Sør -Korea, 05505
- Asan Medical Center
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Ta kontakt med:
- Sarah Hwang
- Telefonnummer: +82-2-3010-8674
- E-post: tpfkzlxl@naver.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Adults aged 19 years or older
- Shoulder pain lasting for at least 3 months
- A pain visual analogue scale (VAS) score of 4 or greater
- Inadequate response to sufficient conservative treatment for at least 3 months, such as medication, injection therapy, physical therapy, or exercise therapy
- Partial-thickness rotator cuff tear confirmed by ultrasonography or magnetic resonance imaging (MRI)
- No restrictions on participation in clinical trial procedures, including hospitalization
Exclusion Criteria:
- Receipt of subacromial injection therapy in the affected shoulder within the past 3 months
- History of rotator cuff surgery on the affected shoulder within the past 6 months
- Previous treatment with a stem cell therapy for the shoulder
- Presence of any of the following shoulder conditions: full-thickness rotator cuff tear, obvious isolated acromioclavicular joint arthropathy, or a clear history of trauma to the shoulder joint within the past 3 months
- Radiologic findings suggestive of or consistent with any of the following: malignancy, severe glenohumeral osteoarthritis, bony abnormalities causing narrowing of the subacromial space, or clear evidence of acute traumatic rotator cuff injury
- Presence of symptomatic cervical spine disease
- Patients with polyarthritis, infectious arthritis, rheumatoid arthritis, or fibromyalgia
- Clinical trial subjects with neurological deficits
- Pregnant or breastfeeding women
- Unwillingness to use an effective method of contraception during participation in the clinical trial
- Presence of any serious disease that may affect participation in this clinical trial, including cardiovascular, renal, hepatic, endocrine, or neoplastic disease
- Inability to understand the questions used to assess the subject's condition, including the visual analogue scale (VAS), or communication difficulties due to psychiatric illness
- Unwillingness to participate in the clinical trial or difficulty in complying with follow-up visits according to the study schedule
- Participation in another clinical trial within 3 months prior to enrollment in this clinical trial
- Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in this clinical trial
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: Placebo komparator
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Administration of normal saline as a placebo control. |
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Eksperimentell: Høydosegruppe
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Administration of high-dose or medium-dose umbilical cord-derived mesenchymal stem cells |
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Eksperimentell: Middels dose-gruppe
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Administration of high-dose or medium-dose umbilical cord-derived mesenchymal stem cells |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in the size of rotator cuff tears determined by MRI
Tidsramme: 6months
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The location, width (AP size), length (ML size), and depth of the rotator cuff tear will be measured on oblique coronal, axial, and sagittal MRI images where the tear is most clearly visualized. The same measurements will be performed on the corresponding planes after administration of the investigational product and compared with those obtained before administration. |
6months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Location and size of the rotator cuff tear assessed by arthroscopy
Tidsramme: 6months
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6months
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Amount and frequency of rescue medication use
Tidsramme: 6months
|
6months
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Adverse events
Tidsramme: 6months
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6months
|
|
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Shoulder pain and disability index(SPADI) Score
Tidsramme: 6months
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The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The minimum value is 0 and the maximum value is 10. "0" means no pain and "10" means the worst pain imaginable in the pain section. "0" means no difficulty and "10" means so difficult it requires help in the pain section. |
6months
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Constant-Murley score
Tidsramme: 6months
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The Constant score assesses pain, function, ROM, and strength. Pain is allotted a maximum of 15 points, activities of daily living (function)20 points, ROM 40 points, and strength 25 points. The component scores are summated to achieve a maximum possible total score of 100. |
6months
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Visual Analog Scale(VAS) pain
Tidsramme: 6months
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Using a ruler, the score is determined by measuring the distance (mm) on the 100mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. |
6months
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Histological Evaluation of Tendon Tissue
Tidsramme: 6months
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If tendon regeneration at the lesion site is confirmed by arthroscopic examination before and after administration of the investigational product, a tissue sample approximately 2 mm in diameter will be collected from the regenerated area and evaluated using the modified Astrom and Movin scoring system. |
6months
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Short tandem repeat (STR) evaluation of tendon tissue
Tidsramme: 6months
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STR testing will be performed using a portion of the collected tendon tissue. The results will be compared with those of the investigational product and the clinical study participant's blood to evaluate the origin of the regenerated tendon tissue. |
6months
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Height
Tidsramme: Visit 1
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The investigator will perform physical examinations according to the clinical study schedule, based on medical judgment. Height will be measured only at Visit 1. Height will be measured in centimeters |
Visit 1
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Weight
Tidsramme: 6months
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The investigator will perform physical examinations at each visit according to the clinical study schedule, based on medical judgment. Body weight will be measured in kilograms at each visit. |
6months
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Systolic and Diastolic blood pressure
Tidsramme: 6months
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The investigator will check systolic and diastolic blood pressure at each visit according to the clinical study schedule, based on medical judgment.systolic and diastolic blood pressure will be measured in a seated position. |
6months
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Pulse rate
Tidsramme: 6months
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The investigator will check pulse rate at each visit according to the clinical study schedule, based on medical judgment. Pulse rate will be measured in a seated position. |
6months
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Complete blood count
Tidsramme: 6months
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Whenever possible, blood samples will be collected after the participant has fasted for at least 9 hours. During the fasting period, participants should not consume any food or beverages other than water. - WBC, RBC, hemoglobin, hematocrit, platelets, and differential count |
6months
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Serum chemistry test
Tidsramme: 6months
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- general: glucose, BUN/creatinine, total protein, albumin, total bilirubin, AST/ALT, ALP, γ-GTP, CK, ESR, CRP Whenever possible, blood samples will be collected after the participant has fasted for at least 9 hours. During the fasting period, participants should not consume any food or beverages other than water. |
6months
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Urinalysis
Tidsramme: 6months
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- pH, specific gravity, protein, glucose, bilirubin, blood, ketone, and microscopic examination |
6months
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Alloimmune test
Tidsramme: 6months
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Clinical study participants will visit the study site at Visit 2 (treatment) and Visit 3 (exploratory efficacy and safety assessment) to undergo alloimmune testing.
If a positive response is observed in the PRA test, the following additional tests will be performed: - HLA Single Ag I, HLA Single Ag II |
6months
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R-3-0023
Plan for individuelle deltakerdata (IPD)
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