Safety and Clinical Effectiveness of A3 SVF in Osteoarthritis
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 15, 2013
CompletedFirst Posted
Study publicly available on registry
September 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedSeptember 4, 2014
September 1, 2014
3 years
March 15, 2013
September 2, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Pain and Inflammation - WOMAC scores, comprehensive inflammation blood panel
one year
Secondary Outcomes (1)
Pain and Mobility Assessment
one year
Study Arms (1)
treatment with A3 SVF
EXPERIMENTALThese patients that have been treated. The control patients that have not been treated.
Interventions
Treatment interarticular and IV with A3 SVF
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr John Huh
Los Angeles, California, 90020, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Barbara Krutchkoff
Institute of Regenerative and Cellular Medicine
- PRINCIPAL INVESTIGATOR
John Huh, MD
ICMS
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr John Huh, Los Angeles
Study Record Dates
First Submitted
March 15, 2013
First Posted
September 20, 2013
Study Start
September 1, 2012
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
September 4, 2014
Record last verified: 2014-09