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

NCT05471752 | Recruiting

• 1 other identifier: TENET(L4165)
• Study Type: observational
• Target: 742
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Musculoskeletal Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

males and females pateints, being ≥18 years old, 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

You may qualify if:

• males and females
• 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

You may not qualify if:

• age \< 18 years old
• patients unable to sign the Informed Consent
• positivity to virological test (HIV, HCV, HBV, TPHA)

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, 20161, Italy

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Central Study Contacts

Direzione Scientifica

CONTACT

00390266214048; direzionescientifica.iog@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 25, 2022
• Study Start: May 11, 2022
• Primary Completion (Estimated): May 11, 2027
• Study Completion (Estimated): May 11, 2027
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

IT (1)