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NCT05471752 Clinical Trial

Isolation, Characterization and Evaluation of the Potential of TissuE-resideNt cElls From Waste Musculoskeletal and Associated Connective Tissues

Musculoskeletal Diseases Clinical Trial

— TENET(L4165)  

Official title:
Isolation, Characterization and Evaluation of the Potential of TissuE-resideNt cElls From Waste Musculoskeletal and Associated Connective Tissues

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05471752
Other study ID # TENET(L4165)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 11, 2022
Est. completion date May 11, 2027

Study information
Verified date July 2022
Source Istituto Ortopedico Galeazzi
Contact Direzione Scientifica
Phone 00390266214048
Email direzionescientifica.iog@grupposandonato.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The general purpose of this study is characterization of tissue-resident cells derived from different musculoskeletal and/or associated connective tissues (such as cartilage, synovial membrane, synovial fluid, bone, adipose tissue and tendons), in order to identify new strategies for the treatment of degenerative and inflammatory musculoskeletal disorders. Cells isolated from different tissue sources will be compared with each other by phenotypic and functional characterization, following culture and treatment with inflammatory elements, drugs and orthobiologics. Moreover, with the aim to assess predictive markers of therapeutic success, a correlation study of the content and properties of the cells isolated from different types of tissue with the clinical profile of the enrolled patients will be conducted.

Recruitment information / eligibility
Status Recruiting
Enrollment 742
Est. completion date May 11, 2027
Est. primary completion date May 11, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - males and females - 18 years old - patients undergoing elective surgery at IRCCS Istituto Ortopedico Galeazzi among which joint surgery (including hip or knee replacement), or anterior cruciate ligament (ACL) reconstruction or rotator cuff repair Exclusion Criteria: - age < 18 years old - patients unable to sign the Informed Consent - positivity to virological test (HIV, HCV, HBV, TPHA)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy IRCCS Istituto Ortopedico Galeazzi Milan

Sponsors (1)
Lead Sponsor Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation beetween patients' age and cell yield The primary outcome of the study will be to identify possible correlations between the cellular yields and patients age. The data from different tissue sources will be analyzed to assess whether the changes are tissue-specific. 5 years
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