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Clinical Trials/NCT05471752
NCT05471752
Recruiting
Not Applicable

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

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 site in 1 country742 target enrollmentMay 11, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Musculoskeletal Diseases
Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Enrollment
742
Locations
1
Primary Endpoint
Correlation beetween patients' age and cell yield
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 11, 2022
End Date
May 11, 2027
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Correlation beetween patients' age and cell yield

Time Frame: 5 years

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.

Study Sites (1)

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