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Safety and Efficacy of Autologous SVF Cells in Treating Patients With Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02846675
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Yin Feng, Shanghai East Hospital

Brief Summary:
it's a self-control, double blind study of autologous adipose-derived stromal vascular fraction (SVF) to treat 50 osteoarthritic knees of grade II or III (K-L scale) under IRB-approved protocol in a feasibility and safety study.

Condition or disease Intervention/treatment Phase
Osteoarthritis Biological: autologous SVF Biological: Placebo Phase 1 Phase 2

Detailed Description:

The adipose-derived SVF was obtained through disaggregation of lipoaspirate and resuspension of the SVF in 2 ml saline, with at least 50 million nucleated SVF cells and a mean viability of 85%, injected per single knee and the other knee treated with placebo.

Cell suspension and placebo will be injected using ultrasound guidance. Safety and knee function will be evaluated by questionaires monthly and MRI in every three months post-op.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Self-control Study: Safety and Efficacy of Autologous Adipose-Derived SVF Cells Delivered Intra-articularly in Patients With Osteoarthritis
Actual Study Start Date : November 1, 2014
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: SVF treatment (random knee)
A random knee (left or right) of subjects will be treated with autologous SVF.
Biological: autologous SVF
SVF will be obtained from lipoaspirates of subjects which will contain more than 5 millions nucleated cells.
Other Name: Stromal Vascular Fraction

Placebo Comparator: placebo treatment (the other knee)
The other knee of subjects will be treated with placebo.
Biological: Placebo
a Placebo treatment without SVF cells




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 6 months ]
    Subjects will be monitored for adverse events


Secondary Outcome Measures :
  1. Change in Pain Scores on the WOMAC Scale at All Follow-up Visits [ Time Frame: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months ]
    Patients outcomes for pain will be scored through questionaires

  2. Change in Function Scores on the WOMAC Scale at All Follow-up Visits [ Time Frame: 1 month, 2 months, 3 months, 4 months, 5 months, 6 months ]
    Patients outcomes for knee function will be scored through questionaires

  3. Change from baseline in MRI imaging [ Time Frame: 3 months & 6 months ]
    Knee function will be assessed by MRI at three time points: pre-op, 3 months and 6 months post-op



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Grade II or Grade III osteoarthritis using Kellgren-Lawrence grading scale (K-L Grade) as diagnosed using weight bearing X-ray, physician review, and/or pre-op MRI.
  • Study Subjects must have failed a minimum of at least two conservative therapies, spanning a period of at least 3 months.
  • Study Subjects must be willing to voluntarily give written Informed Consent to participate in the study and sign the Health Insurance Portability and Accountability Act (HIPAA) authorization before any study procedures are performed.
  • Subjects will be in good health (ASA Class I-II) with a BMI < 35.
  • Subjects must have continued pain in the knee despite conservative therapies for at least 3 months.
  • Subjects with unilateral disease must present with symptomatic knee pain using the WOMAC subscale for pain.
  • Subjects must speak, read and understand English.
  • Subjects must be reasonably able to return for multiple follow-up visits.

Exclusion Criteria:

  • Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study.
  • Life expectancy < 6 months due to concomitant illnesses.
  • Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
  • Active infectious disease. Patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM > IgG) and/or syphilis will have an expert consultation as to patient eligibility based on the patient's infectious status
  • Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
  • Patients on chronic immunosuppressive transplant therapy
  • Systolic blood pressure (supine) ≤90 mm Hg or greater than 180mmHg
  • Resting heart rate > 100 bpm;
  • Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
  • History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
  • Active clinical infection
  • Unwilling and/or not able to give written informed consent.

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): NCT02846675


Locations
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China, Shanghai
Shanghai East Hospital
Shanghai, Shanghai, China, 200000
Sponsors and Collaborators
Shanghai East Hospital

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Responsible Party: Yin Feng, Chief Physician, Shanghai East Hospital
ClinicalTrials.gov Identifier: NCT02846675     History of Changes
Other Study ID Numbers: DFSC-2014(CR)-03
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Yin Feng, Shanghai East Hospital:
SVF
Stromal Vascular Fraction
osteoarthritis(OA)
knee
adipose

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