Phase 1
N=6
ADSC Injections for Pain Management of Osteoarthritis in the Human Knee Joint
Osteoarthritis of the Knee
Bottom Line
View on ClinicalTrials.gov: NCT02357485 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Safety as Measured by Adverse Events — 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- ADSC (Biological)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Fodor, Peter B, M.D.
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety as Measured by Adverse Events |
— | — |
| SECONDARY Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC) |
32.9; 10.8; 9.3 | <0.004 sig |
| SECONDARY Comparison of Baseline Score and 1 Year Score in Visual Analog Scale (VAS) for Pain |
5.9; 1.8; 2.0 | <0.001 sig |
| SECONDARY Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion |
136.6; 143.6 | 0.053 |
| SECONDARY Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG). |
5.4; 2.8 | 0.003 sig |
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.
Eligibility Criteria
Inclusion Criteria
- 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 -
Exclusion Criteria
- patient parameters falling outside of the inclusion criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02357485). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.