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

Phase 1

Completed

• Conditions: Osteoarthritis
• Interventions: Biological: autologous SVF; Biological: Placebo

• Registration Number: NCT02846675
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-11-01
• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-27
• Primary Completion: 2017-07-31
• Study Completion: 2018-01-31
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SVF treatment (random knee)	autologous SVF	A random knee (left or right) of subjects will be treated with autologous SVF.
placebo treatment (the other knee)	Placebo	The other knee of subjects will be treated with placebo.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	6 months	Subjects will be monitored for adverse events

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai East Hospital; 🇨🇳 Shanghai, Shanghai, China