Clinical trial NCT02357485: ADSC Injections for Pain Management of Osteoarthritis in the Human Knee Joint
Official title: Adipose Derived Stromal Cell (ADSC) Injections for Pain Management of Osteoarthritis in the Human Knee Joint
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis of the Knee
Keywords: ADSC
osteoarthritis
knee
adipose
Lead sponsor: Fodor, Peter B, M.D.
Sponsor class: INDIV
Collaborators: name: Plastic Surgery Education and Research Foundation
First posted: 2015-02-06
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This safety and feasibility study used autologous adipose-derived stromal cells, the stromal vascular fraction, to treat 8 osteoarthritic 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 IRB-approved protocol. Evaluation of the safety of intra-articular injection of the stromal vascular fraction cells was the primary objective of the study. Adipose-derived stromal vascular cells were obtained through enzymatic disaggregation of lipoaspirate, resuspended in 3 ml of Lactated Ringer's Solution, and injected directly into the intra-articular space with a mean of 12 million viable nucleated SVF cells per knee.

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

Primary outcomes:
measure: Safety as Measured by Adverse Events
timeFrame: Entire Study (1 year)
Secondary outcomes:
measure: Comparison of Baseline Score and 1 Year Score in Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: Baseline to 1 year
measure: Comparison of Baseline Score and 1 Year Score in Visual Analog Scale (VAS) for Pain
timeFrame: Baseline to 1 year
measure: Comparison of Baseline and 3 Months Measures of Knee Flexion for Range of Motion
timeFrame: Baseline to 3 months
measure: Comparison of Baseline Score and 3 Months Score in Timed-Up-and-Go (TUG).
timeFrame: baseline to 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Private Practice
name: Peter B Fodor, M.D.
role: PRINCIPAL_INVESTIGATOR
References: