NCT02846675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

2.7 years

First QC Date

July 25, 2016

Last Update Submit

September 10, 2018

Conditions

Osteoarthritis

Keywords

SVFStromal Vascular Fractionosteoarthritis(OA)kneeadipose

Outcome Measures

Primary Outcomes (1)

  • Incidence of Treatment-Emergent Adverse Events

    Subjects will be monitored for adverse events

    6 months

Secondary Outcomes (3)

  • 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

  • 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

  • Change from baseline in MRI imaging

    3 months & 6 months

Study Arms (2)

SVF treatment (random knee)

EXPERIMENTAL

A random knee (left or right) of subjects will be treated with autologous SVF.

Biological: autologous SVF

placebo treatment (the other knee)

PLACEBO COMPARATOR

The other knee of subjects will be treated with placebo.

Biological: Placebo

Interventions

autologous SVFBIOLOGICAL

SVF will be obtained from lipoaspirates of subjects which will contain more than 5 millions nucleated cells.

Also known as: Stromal Vascular Fraction
SVF treatment (random knee)
PlaceboBIOLOGICAL

a Placebo treatment without SVF cells

placebo treatment (the other knee)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

July 25, 2016

First Posted

July 27, 2016

Study Start

November 1, 2014

Primary Completion

July 31, 2017

Study Completion

January 31, 2018

Last Updated

September 11, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will share

Locations

CN(1)