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

A Self-control Study: Safety and Efficacy of Autologous Adipose-Derived SVF Cells Delivered Intra-articularly in Patients With Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Biological: autologous SVF; Biological: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Shanghai East Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	Subjects will be monitored for adverse events	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Scores on the WOMAC Scale at All Follow-up Visits	Patients outcomes for pain will be scored through questionaires	1 month, 2 months, 3 months, 4 months, 5 months, 6 months
Change in Function Scores on the WOMAC Scale at All Follow-up Visits	Patients outcomes for knee function will be scored through questionaires	1 month, 2 months, 3 months, 4 months, 5 months, 6 months
Change from baseline in MRI imaging	Knee function will be assessed by MRI at three time points: pre-op, 3 months and 6 months post-op	3 months & 6 months

Collaborators and Investigators

• Sponsor: Shanghai East Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): January 31, 2018

Study Registration Dates

• First Submitted: July 25, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (Estimate): July 27, 2016

Study Record Updates

• Last Update Posted (Actual): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 10, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: knee; Stromal Vascular Fraction; adipose; SVF; osteoarthritis(OA)
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: DFSC-2014(CR)-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes