Autologous Adipose-Derived Stromal Cells Delivered Intra-articularly in Patients With Osteoarthritis.

November 21, 2017 updated by: Ageless Regenerative Institute

An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intra- Articularly in Patients With Osteoarthritis

This will be an open-label, non-randomized, multi-center, patient sponsored study of Adipose-Derived Stromal Vascular Fraction (AD-SVF) implantation performed intra-articularly to affected joints.

The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed Osteoarthritis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

AD-SVF will be collected from the patient's adipose-derived tissue (body fat). Using local anesthesia, Liposuction will be performed to collect the adipose tissue specimen. The adipose tissue is then transferred to the laboratory for separation of AD-SVF. In addition, patient's peripheral blood will be collected for isolation of platelet rich plasma (PRP), which are then combined with the AD-SVF for intra-articular administration of affected joint.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Aventura, Florida, United States, 33180
        • Ageless Institute LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and Females between Age 18 and 80 years.
  • Patient with current proven diagnosis of Osteoarthritis, with consistent symptomatology
  • Up to date on all age and gender appropriate cancer screening per American Cancer Society.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Autologous Adipose-derived Stromal Vascular Fraction infusion
Intervention: AD-SVF infusion directly into affected joints.
Procedure: Liposuction with Local Anesthesia
Liposuction under tumescent anesthesia for adipose tissue harvesting.
Other Names:
  • Lipoplasty
  • Liposculpture
  • Suction-assisted fat removal
Biological: Intra articular infusion of AD-SVF

Adipose tissue is available in most patients for harvest through minimally invasive procedures such as liposuction. AD-SVF can be obtained in large quantities after processing of adipose tissue in the laboratory.

  • AD-SVF to promote tissue regeneration and repair with their ability to secrete various growth factors that can modulate host tissue environment.
  • Patient's AD-SVF combined with PRP are used for direct intra-articular injection after processing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Visual Analogue Scale (VAS)
Time Frame: 3 months, 6 months
For pain score, functional rating index, visual analog scale (VAS), physical therapy (PT), and range of motion (ROM) were determined as previously described. The patient was restricted from taking steroids, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) for one week prior to the procedure.
3 months, 6 months
Change from Baseline of Quality of life scores
Time Frame: 3 months, and 6 months
3 months, and 6 months
Change from Baseline of Reduction in analgesics
Time Frame: Baseline, 3 months, 6 months
Baseline, 3 months, 6 months
Number of adverse events reported
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in x-ray, sonogram, or MRI imaging of affected joint compared to baseline.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ageless Regenerative Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

September 28, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 3, 2012

Study Record Updates

Last Update Posted (Actual)

November 24, 2017

Last Update Submitted That Met QC Criteria

November 21, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-US-OR-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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