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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05120700
Recruitment Status : Not yet recruiting
First Posted : November 15, 2021
Last Update Posted : November 15, 2021
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.


Condition or disease Intervention/treatment Phase
Cell- and Tissue-Based Therapy Cartilage Injury Knee Injuries Biological: Synovial Tissue and Fat Pad Stromal Vascular Fraction Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Synovial Tissue and Fat Pad Stromal Vascular Fraction Bioengineering in Patients With Knee Articular Cartilage Injury, Clinical Study Phase I/II
Estimated Study Start Date : April 2022
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : May 2025

Arm Intervention/treatment
Experimental: Stromal vascular fraction
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
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




Primary Outcome Measures :
  1. Cartilage Repair [ Time Frame: The primary outcomes will be assessed preoperatively in the allocation date; at 6 months postoperatively; and at 12 months postoperatively ]
    3T magnetic resonance imaging to evalate quantity and quality of cartilage repair

  2. Visual Analog Score for pain [ Time Frame: The primary outcomes will be assessed preoperatively in the allocation date; at 6 months postoperatively; and at 12 months postoperatively ]
    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.

  3. International Knee Documentation Committee Questionnaire [ Time Frame: The primary outcomes will be assessed preoperatively in the allocation date; at 6 months postoperatively; and at 12 months postoperatively ]
    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

  4. Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: The primary outcomes will be assessed preoperatively in the allocation date; at 6 months postoperatively; and at 12 months postoperatively ]
    WOMAC evaluates the condition of patients with osteoarthritis of the knee, including pain, stiffness, and physical functioning of the join

  5. Perioperative and post-operative complications [ Time Frame: Since hospital admission for the procure until hospital discharge; and monthly after discharge, until 12 months postoperatively ]
    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


Secondary Outcome Measures :
  1. Measurement of health resources expenses [ Time Frame: Since allocation date; until 12 months postoperatively ]
    Resources expenses with the procedure to ensure compatibility, reproducibility and generalizability of the technique



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05120700


Contacts
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Contact: Tiago L Fernandes, Phd +5511983830123 tiagot86@hotmail.com
Contact: Caio G Tabet, Md +5532987008056 caiotabet@hotmail.com

Sponsors and Collaborators
University of Sao Paulo General Hospital
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT05120700    
Other Study ID Numbers: 4.285.308
First Posted: November 15, 2021    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sao Paulo General Hospital:
Tissue engineering
Cell- and Tissue-Based Therapy
Mesenchymal Stem Cells
Cartilage
Knee.
Additional relevant MeSH terms:
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Wounds and Injuries
Knee Injuries
Leg Injuries