Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis
Primary Purpose
Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
treatment with A3 SVF
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury.
- Patients range from 15-90 years of age.
- Female patients not pregnant or lactating.
- Patients with a history of or current corticosteroid therapy will only be eligible if use is suspended from 1 month prior to cell therapy.
- Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
- Patients with adequate renal function, creatinine ≤ 1.5 mg/dl.
- Patients with adequate blood coagulation activity, PT(INR) < 1.5, APTT <1.5×control.
Exclusion Criteria:
- Diagnosis of cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision.
- Signs and symptoms of clinically significant cardiac disease.
- Diagnosis of a transient ischemic attack in the 6 months prior to screening,
- Known allergy to anesthetic or any other components of study.
- Patients infected with hepatitis B, C or HIV.
- Patients with Body Mass Index (BMI) > 39kg/m2 .
- Any other cardiovascular illness that in the opinion of the investigator would render a patient unsuitable to participate in the study.
Sites / Locations
- Dr John HuhRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment with A3 SVF
Arm Description
These patients that have been treated. The control patients that have not been treated.
Outcomes
Primary Outcome Measures
Pain and Inflammation - WOMAC scores, comprehensive inflammation blood panel
Secondary Outcome Measures
Pain and Mobility Assessment
Full Information
NCT ID
NCT01947348
First Posted
March 15, 2013
Last Updated
September 2, 2014
Sponsor
Institute of Regenerative and Cellular Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01947348
Brief Title
Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis
Official Title
Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
September 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Regenerative and Cellular Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To purpose of this study is to determine if treatment with SVF (Stromal Vascular Fraction) has an effect on pain and inflammation associated with Osteoarthritis.
Detailed Description
This is a prospective non-randomized, clinical study of 30 patients to determine safety and treatment potential of A3(Adult Autologous Adipose) SVF for the pain and inflammation associated with Osteoarthritis.
Patients will be treated for Osteoarthritis due to degeneration or chronic injury. They will be given autologous SVF extract derived by the A3 method mixed with activated platelets from a PRP(platelet rich plasma) preparation as direct injections to the effected joints. Outcomes will be tracked with WOMAC (Western Ontario and McMaster Universities Arthritis Index), AUSCAN(Australian Hand Osteoarthritis Index) scores, and a general blood panel in order to evaluate systemic effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment with A3 SVF
Arm Type
Experimental
Arm Description
These patients that have been treated. The control patients that have not been treated.
Intervention Type
Procedure
Intervention Name(s)
treatment with A3 SVF
Other Intervention Name(s)
A3 SVF, Cell Extracts, Adipose Derived Stem Cells
Intervention Description
Treatment interarticular and IV with A3 SVF
Primary Outcome Measure Information:
Title
Pain and Inflammation - WOMAC scores, comprehensive inflammation blood panel
Time Frame
one year
Secondary Outcome Measure Information:
Title
Pain and Mobility Assessment
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury.
Patients range from 15-90 years of age.
Female patients not pregnant or lactating.
Patients with a history of or current corticosteroid therapy will only be eligible if use is suspended from 1 month prior to cell therapy.
Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
Patients with adequate renal function, creatinine ≤ 1.5 mg/dl.
Patients with adequate blood coagulation activity, PT(INR) < 1.5, APTT <1.5×control.
Exclusion Criteria:
Diagnosis of cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision.
Signs and symptoms of clinically significant cardiac disease.
Diagnosis of a transient ischemic attack in the 6 months prior to screening,
Known allergy to anesthetic or any other components of study.
Patients infected with hepatitis B, C or HIV.
Patients with Body Mass Index (BMI) > 39kg/m2 .
Any other cardiovascular illness that in the opinion of the investigator would render a patient unsuitable to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Huh, MD
Phone
213 384 1717
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Krutchkoff
Organizational Affiliation
Institute of Regenerative and Cellular Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
John Huh, MD
Organizational Affiliation
ICMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr John Huh
City
Los Angeles
State/Province
California
ZIP/Postal Code
90020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Huh, MD
Phone
213-384-1717
Email
drjhuh@gmail.com
First Name & Middle Initial & Last Name & Degree
John Huh, MD
12. IPD Sharing Statement
Links:
URL
http://www.cellmedicinesociety.org/
Description
IRB
URL
http://www.auscan.org/womac/index.htm
Description
Info regarding outcome measures
Learn more about this trial
Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis
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