Osteoarthritis
Conditions
Brief summary
Stromal vascular fraction (SVF) can easily be obtained from a mini-lipoaspirate procedure of fat tissue and platelet rich plasma (PRP) can be obtained from peripheral blood. Evaluated the safety and preliminary efficacy of administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2.
Interventions
BIOLOGICALIntra-articular injection of SVF plus PRP
administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2
Sponsors
Anupam Hospital
RegennMed Research and Therapeutics Delhi
Bioheart, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients age 50 or older who present with symptomatic primary osteoarthritis of the knee * daily pain for the previous 3 months * analgesics usage at least once a week * less than 30 minutes of morning stiffness * WOMAC score of ≤ 75 in the target knee * Brandt Radiographic Grading Scale of Osteoarthritis grade 1 and 2
Exclusion criteria
* evidence of secondary knee osteoarthritis * severe osteoarthritis (Joint space width - JSW \< 2 mm) * prior intra articular injections within the previous one year prior to inclusion * patients with clinically significant systemic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| WOMAC (Western Ontario and McMaster Universities Arthritis Index) | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Six minute walk distance | 1 year |
Outcome results
None listed