ADSC Injections for Pain Management of Osteoarthritis in the Human Knee Joint
Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint
1 other identifier
interventional
6
0 countries
N/A
Brief Summary
This safety and feasibility study used autologous adipose-derived stromal cells (ADSC), the stromal vascular fraction (SVF), to treat 8 osteoarthritic (OA) knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under Institutional Review Board (IRB) approved protocol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2014
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
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 31, 2015
CompletedFirst Posted
Study publicly available on registry
February 6, 2015
CompletedResults Posted
Study results publicly available
March 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJune 30, 2015
June 1, 2015
1.2 years
January 31, 2015
February 13, 2015
June 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety as Measured by Adverse Events
Adverse Events were recorded during the entirety of the study.
Entire Study (1 year)
Secondary Outcomes (4)
Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Baseline to 1 year
Comparison of Baseline Score and 1 Year Score in Visual Analog Scale (VAS) for Pain
Baseline to 1 year
Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion
Baseline to 3 months
Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG).
baseline to 3 months
Study Arms (1)
Treatment arm
EXPERIMENTALSingle injection of ADSC
Interventions
Eligibility Criteria
You may qualify if:
- voluntarily provided written Informed Consent
- ages 20-70
- male or female
- grades I-III radiologically documented OA of one or both knees
- American Society Anaesthesiologists (ASA) physical status class I-II and a • BMI less than 35
- knee pain graded as greater than 3 out of 10 on screening questionnaire
- able to speak, read and understand English -
You may not qualify if:
- current oral or parenteral steroid or blood thinner use
- hyaluronic acid-based injection to the affected knee joint within the previous six months
- corticosteroid injection to the affected knee joint within the previous three months
- end stage (Grade IV) OA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Peter Fodor, MD
- Organization
- UCLA Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Peter B Fodor, M.D.
Private Practice
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDIV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Peter B. Fodor, M.D.
Study Record Dates
First Submitted
January 31, 2015
First Posted
February 6, 2015
Study Start
March 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
June 30, 2015
Results First Posted
March 27, 2015
Record last verified: 2015-06