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Fat-Derived Cell Therapy for Osteoarthritis
Study Summary
This trial is testing whether it is safe and feasible to inject a person's own fat-derived cells into their knee to treat osteoarthritis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have not had knee surgery in the past year.My knee's condition is stable.I understand and agree to follow the study's treatment plan and procedures.I have seen my primary care doctor for a check-up within the last year.I have a history of blood disorders such as anemia or low platelet counts.I do not have any ongoing infectious diseases like TB, HIV, hepatitis, or syphilis.I am on long-term medication that weakens my immune system.I have had a skin infection in my knee within the last 6 months or have one now.I am currently taking blood thinners or clopidogrel.I have a condition like rheumatoid arthritis or lupus.I haven't had injections in my knee in the last 3 months.I have had falls needing medical help or have trouble walking steadily.I have had cancer other than skin cancer in the last 5 years not related to my knee.I cannot have MRI scans due to health reasons or I choose not to have them.My blood and urine tests are within normal ranges, except for one minor issue that can be retested.I am on stable pain medication for osteoarthritis, supervised by my doctor.I have tried treatments like physical therapy or medication for over 3 months.I am not pregnant, can use birth control, and will do so for 1 year after treatment.I have been on a stable electrotherapy or acupuncture treatment for my arthritis for at least 4 weeks.I have a blood vessel or nerve condition in one of my legs.I have taken medication for rheumatic disease in the last 3 months.I do not have major heart, brain, kidney, liver, bone, or hormone-related health issues.I have a specific knee condition like arthritis or CPPD.I am between 40 and 75 years old.I can walk on my own without any help.I have had a joint infection in my knee.I have not been on a stable dose of NSAIDs for 4 weeks.I need X-rays due to major issues with my body's alignment.My knee locks, catches, or suddenly gives way.I currently use tobacco or nicotine products.My knee's shape is unusual due to a birth defect or injury, affecting treatment.I haven't taken any herbal therapies or supplements in the last 4 weeks and am willing to avoid them during the study.My knee arthritis is graded from mild to severe.
- Group 1: Placebo Group
- Group 2: SVF (Stromal Vascular Fraction) Group
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this experimental procedure require subjects to be of a particular age?
"This research is open to those aged 40 or older but not exceeding the age of 70."
How many individuals have volunteered for this experiment?
"Affirmative. The clinical trial is actively in session, as per the information on clinicaltrials.gov; it was first introduced on July 1st 2019 and last updated on May 26th 2022. 30 participants will be accepted at 2 different locations for this medical study."
Are there any vacancies left for participants in this clinical experiment?
"Indeed, clinicaltrials.gov displays that this trial is currently seeking participants - it was posted on July 1st 2019 and last updated on May 26th 2022. Specifically, the study requires 30 subjects across 2 locations to be recruited."
To whom is this research open for participation?
"This clinical trial requires 30 participants, within the ages of 40 to 70 who suffer from arthrosis. Other prerequisites for enrolment include: Females with childbearing potential must take a pregnancy test and use adequate contraception (hormonal or barrier method or abstinence) between screening and 1 year after drug treatment ends; females with childbearing potential are defined as either premenopausal without sterilization surgery, or post-menopausal for less than 2 years; urine tests will be conducted prior to administering study drugs while serum tests can be done at a central lab; candidates should also have no issues walking unaided by any device such as walkers"
Could you elucidate the potential risks associated with Autologous Adipose-Derived SVF (Stromal Vascular Fraction) treatments?
"There is limited data backing Autologous Adipose-Derived SVF's safety and efficacy, thus it received a score of 1."
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