Study Summary
This trial will test a new treatment for osteoarthritis pain that involves injecting fat cells into the knee joint.
- Osteoarthritis of the Knee
Video Summary
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 12 months
Trial Safety
Trial Design
2 Treatment Groups
Stromal Vascular Fraction (SVF)
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
124 Total Participants · 2 Treatment Groups
Primary Treatment: GID SVF-2 Device System · Has Placebo Group · N/A
Trial Logistics
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 35 - 85 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Pennsylvania | 18.2% |
| Florida | 18.2% |
| California | 18.2% |
| Other | 45.5% |
How old are they?
| 65+ | 33.3% |
| 18 - 65 | 66.7% |
What site did they apply to?
| UC Davis | 28.6% |
| New Jersey Regenerative Institute | 14.3% |
| OrthoCarolina Research Institute | 14.3% |
| Other | 42.9% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Why did patients apply to this trial?
- "I have been struggling with my knee swelling for the past 8 years, following ACL reconstruction in 2015 and especially after a manisectomy in 2020. Whenever they drain my knee there is a lot of cartilage floating in the fluid."
- "It is closer than another trial I applied for. It didn't come up at first search, I have tried so all the treatments and still have pain on moverment 10 on the painscale. and ache 5 for rest, I cannot afford the treatment offered by a Dr in my Ortho NP"
How many prior treatments have patients received?
| 2 | 33.3% |
| 3+ | 66.7% |
How responsive is this trial?
Typically responds via
| Phone Call | 66.7% |
| 33.3% | |
Most responsive sites:
- OrthoCarolina Research Institute: < 24 hours
- New Jersey Regenerative Institute: < 48 hours
Average response time
- < 2 Days
- Garza, Jaime R., Richard E. Campbell, Fotios P. Tjoumakaris, Kevin B. Freedman, Lawrence S. Miller, Daniel Santa Maria, and Bradford S. Tucker. 2020. “Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-blinded Prospective Randomized Controlled Clinical Trial”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546519899923.
- Garza, Jaime R., Richard E. Campbell, Fotios P. Tjoumakaris, Kevin B. Freedman, Lawrence S. Miller, Daniel Santa Maria, and Bradford S. Tucker. 2020. “Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-blinded Prospective Randomized Controlled Clinical Trial”. The American Journal of Sports Medicine. SAGE Publications. doi:10.1177/0363546519899923.
- 2020. "Autologous Adipose-derived Stromal Vascular Fraction for Treatment of Knee Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04440189.
Frequently Asked Questions
Is eligibility for this experiment restricted to those over 20 years of age?
"Based on the specified enrolment requirements, it is necessary for participants to be aged between 35 and 85 years old." - Anonymous Online Contributor
How many people are participating at the maximum capacity of this trial?
"This trial requires the enrollment of 124 eligible patients. Two locations in North Carolina and Ohio, OrthoCarolina Research Institute and Wake Forest University Health Sciences respectively, are amongst the sites that welcome participants." - Anonymous Online Contributor
Are there currently any enrollment opportunities for this experiment?
"According to the available information on clinicaltrials.gov, this medical study is actively enrolling candidates at present; it was initially posted in October 2020 and last modified in May 2022." - Anonymous Online Contributor
How many health care facilities are currently conducting this research experiment?
"At present, 10 medical facilities are enrolling patients for this study. Locations range from Charlotte to Columbus and also include other sites across the country. To reduce travel obligation, it is recommended that potential participants select a trial centre near their residence." - Anonymous Online Contributor
Is registration for this experiment open to new participants?
"To meet the requirements of this experiment, subjects should be between 35 and 85 years old with a diagnosis of knee osteoarthritis. This trial is slated to enroll 124 volunteers." - Anonymous Online Contributor