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

Primary Purpose

Osteoarthritis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Liposuction with Local Anesthesia
Intra articular infusion of AD-SVF
Sponsored by
Ageless Regenerative Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Arthritis, Joint pain, Articular cartilage, Mesenchymal stem cells, Autologous, Adipose tissue

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ageless Institute LLC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous Adipose-derived Stromal Vascular Fraction infusion

Arm Description

Intervention: AD-SVF infusion directly into affected joints.

Outcomes

Primary Outcome Measures

Change from Baseline in Visual Analogue Scale (VAS)
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.
Change from Baseline of Quality of life scores
Change from Baseline of Reduction in analgesics
Number of adverse events reported

Secondary Outcome Measures

Change from Baseline in x-ray, sonogram, or MRI imaging of affected joint compared to baseline.

Full Information

First Posted
September 28, 2012
Last Updated
November 21, 2017
Sponsor
Ageless Regenerative Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01739504
Brief Title
Autologous Adipose-Derived Stromal Cells Delivered Intra-articularly in Patients With Osteoarthritis.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
company dissolved
Study Start Date
March 1, 2014 (Actual)
Primary Completion Date
April 1, 2017 (Actual)
Study Completion Date
April 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ageless Regenerative Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Arthritis, Joint pain, Articular cartilage, Mesenchymal stem cells, Autologous, Adipose tissue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous Adipose-derived Stromal Vascular Fraction infusion
Arm Type
Experimental
Arm Description
Intervention: AD-SVF infusion directly into affected joints.
Intervention Type
Procedure
Intervention Name(s)
Liposuction with Local Anesthesia
Other Intervention Name(s)
Lipoplasty, Liposculpture, Suction-assisted fat removal
Intervention Description
Liposuction under tumescent anesthesia for adipose tissue harvesting.
Intervention Type
Biological
Intervention Name(s)
Intra articular infusion of AD-SVF
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Visual Analogue Scale (VAS)
Description
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.
Time Frame
3 months, 6 months
Title
Change from Baseline of Quality of life scores
Time Frame
3 months, and 6 months
Title
Change from Baseline of Reduction in analgesics
Time Frame
Baseline, 3 months, 6 months
Title
Number of adverse events reported
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from Baseline in x-ray, sonogram, or MRI imaging of affected joint compared to baseline.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon McQuillan, MD
Organizational Affiliation
Ageless Regenerative Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ageless Institute LLC
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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