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Autologous Micro-fragmented Adipose Tissue Injection for Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03788265
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
Knee osteoarthritis (OA) is characterized by loss of cartilage leading to instability, reduced range of motion, and functional limitations. Current treatment has various limitations so that alternative options to restore function and alleviate joint pain, with the ultimate goal of healing damaged articular cartilage are needed. Mesenchymal stem cells (MSCs) therapy has shown promising results. However, MSCs are limited by complex regulatory issues. Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue through mild mechanical force. This procedure is enzyme free and requires no clonal expansion or manipulation. The goal of this study is to evaluate the possible benefits of reduced joint pain and increased joint functionality in patients with knee osteoarthritis after the injection of Lipogems.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: Lipogems Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Autologous Micro-fragmented Adipose Tissue Intra-articular Injection for Knee Osteoarthritis
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: injection Device: Lipogems
harvest and inject micro-fragment adipose tissue




Primary Outcome Measures :
  1. Change in Visual Analog Pain Scale (VAS) Over Time [ Time Frame: Pre-op, then post-op: 1 month, 3 months, 6 months, 1 year, 2 years ]
    Scaled pain score to assess change in a patient's knee pain over time. Pain level is marked on a 100 mm line with the 0 mm corresponding to "no pain" and the 100 mm corresponding to 10/10 pain. Using a ruler, the score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).


Secondary Outcome Measures :
  1. Change in the knee injury and osteoarthritis score (KOOS) Over Time [ Time Frame: Pre-op, then post-op: 1 month, 3 months, 6 months, 1 year, 2 years ]
    Patient self-reported outcome measure to assess the patient's opinion about their knee and associated issues. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated by adding the subscales together.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age of eighteen or older
  • Diagnosis of symptomatic knee osteoarthritis
  • Radiographic evidence of knee osteoarthritis
  • Failure of conservative treatment

Exclusion Criteria:

  • Treatment with any intra-articular knee injection within 8 weeks before surgery
  • Any disease or condition potential to interfere study outcome
  • Under 18 years of age

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): NCT03788265


Contacts
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Contact: Xuesong Dai, MD., PhD +8687783777

Locations
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China, Zhejiang
Second affiliated hospital, school of medicine, Zhejiang Uni. Recruiting
Hangzhou, Zhejiang, China, 310058
Contact: Xuesong Dai    +8687783777      
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University

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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03788265     History of Changes
Other Study ID Numbers: lipo-knee OA-dxs
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases