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Synovial Tissue and Fat Pad Stromal Vascular Fraction Bioengineering in Patients With Knee Articular Cartilage Injury

NCT05120700 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-11-15

No results posted yet for this study

Summary

A phase I/II clinical trial (first in human) to assess the effectiveness and safety of the treatment of cartilage injury with a tissue engineering construct composed of stromal vascular fraction collected from the synovial membrane and infrapatellar fat of the injured knee, submitted to enzymatic processing in a single surgical time, associated with a collagen scaffold.

The primary outcomes will be assessed by 3T magnetic resonance imaging, quality of life and knee function questionnaires, in addition to perioperative and post-operative complications. Secondary outcomes will be evaluated by measuring the health resources used to ensure compatibility, reproducibility and generalizability of the technique.

The authors believe that adverse events will be similar to current surgical procedures and that there will be an improvement in knee function scores and quality of life of patients undergoing the procedure.

Conditions

  • Cell- and Tissue-Based Therapy
  • Cartilage Injury
  • Knee Injuries

Interventions

BIOLOGICAL

Synovial Tissue and Fat Pad Stromal Vascular Fraction

Treatment of cartilage injury with a tissue engineering construct. It will be composed of stromal vascular fraction collected from the synovial membrane and infrapatellar fat of the injured knee, submitted to enzymatic processing in a single surgical time, associated with a collagen scaffold

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-30
Primary Completion
2025-04-30
Completion
2025-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05120700 on ClinicalTrials.gov