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

NCT05120700 | Unknown Phase 1

• 1 other identifier: 4.285.308
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Tissue engineering; Cell- and Tissue-Based Therapy; Mesenchymal Stem Cells; Cartilage; Knee.

Outcome Measures

Primary Outcomes (5)

• Cartilage Repair

  3T magnetic resonance imaging to evalate quantity and quality of cartilage repair

  The primary outcomes will be assessed preoperatively in the allocation date; at 6 months postoperatively; and at 12 months postoperatively

• Visual Analog Score for pain

  A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge.

  The primary outcomes will be assessed preoperatively in the allocation date; at 6 months postoperatively; and at 12 months postoperatively

• International Knee Documentation Committee Questionnaire

  The questionnaire looks at 3 categories: symptoms, sports activity, and knee function. The symptoms subscale helps to evaluate things such as pain, stiffness, swelling and giving-way of the knee

  The primary outcomes will be assessed preoperatively in the allocation date; at 6 months postoperatively; and at 12 months postoperatively

• Western Ontario and McMaster Universities Osteoarthritis Index

  WOMAC evaluates the condition of patients with osteoarthritis of the knee, including pain, stiffness, and physical functioning of the join

  The primary outcomes will be assessed preoperatively in the allocation date; at 6 months postoperatively; and at 12 months postoperatively

• Perioperative and post-operative complications

  Assessment of wound infections, pneumonia, cardiovascular and cerebrovascular events, deep vein thrombosis and/or pulmonary embolisms, ICU-admission, hospital readmission and need for complication surgery

  Since hospital admission for the procure until hospital discharge; and monthly after discharge, until 12 months postoperatively

Secondary Outcomes (1)

• Measurement of health resources expenses

  Since allocation date; until 12 months postoperatively

Study Arms (1)

Stromal vascular fraction

EXPERIMENTAL

Treatment of cartilage injury with a tissue engineering construct.The patients will be adults diagnosed with a single, 3 to 6 cm2 full-thickness cartilage lesion, symptomatic and with no improvement with non-operative treatment.

Biological: Synovial Tissue and Fat Pad Stromal Vascular Fraction

Interventions

Synovial Tissue and Fat Pad Stromal Vascular Fraction BIOLOGICAL

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

Stromal vascular fraction

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients diagnosed with a single, 3 to 6 cm2 full-thickness cartilage lesion, symptomatic and without improvement with non-operative treatment.

You may not qualify if:

• Any previous surgery to treat the injury, presence of pathology in the contralateral knee or other pathologies that interfere with recovery. Serological tests will be performed for autologous donors, complete serology: HIV, HCV, HBsAg, anti HBC, HTLV I and II, syphilis and Chagas.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Central Study Contacts

Tiago L Fernandes, Phd

CONTACT

+5511983830123; tiagot86@hotmail.com

Caio G Tabet, Md

CONTACT

+5532987008056; caiotabet@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 15, 2021
• Study Start: April 1, 2022
• Primary Completion: April 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 15, 2021

Record last verified: 2021-10