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Stem Cell Therapy
Fat-Derived Cell Therapy for Osteoarthritis
Phase 1
Recruiting
Led By Shane A Shapiro
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinically stable target knee.
Male or female ages 40-75 years
Must not have
Surgery on the index knee within 1 year of study enrollment.
History of blood dyscrasia, including but not limited to anemia, thrombocytopenia, and monoclonal gammopathy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
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.
Who is the study for?
This trial is for men and women aged 40-75 with knee osteoarthritis grades 2 or 3, who can walk unassisted and have tried other treatments like physical therapy or anti-inflammatory drugs. Women must not be pregnant but if they become so, will be monitored. Participants should understand the study requirements including fat harvesting and follow-up visits.
What is being tested?
The trial is testing injections of a patient's own adipose-derived stromal vascular fraction (SVF) against a placebo to see if it's safe and works for treating knee osteoarthritis. It involves extracting SVF from the patient’s body fat, then injecting it into their arthritic knee.
What are the potential side effects?
Potential side effects may include reactions at the injection site such as pain or swelling, infection risk due to the procedure, and any adverse effects related to fat harvesting like bruising or discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My knee's condition is stable.
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I am between 40 and 75 years old.
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I can walk on my own without any help.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had knee surgery in the past year.
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I have a history of blood disorders such as anemia or low platelet counts.
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I do not have any ongoing infectious diseases like TB, HIV, hepatitis, or syphilis.
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I am on long-term medication that weakens my immune system.
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I am currently taking blood thinners or clopidogrel.
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I have a condition like rheumatoid arthritis or lupus.
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I have had falls needing medical help or have trouble walking steadily.
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I cannot have MRI scans due to health reasons or I choose not to have them.
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I have a blood vessel or nerve condition in one of my legs.
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I do not have major heart, brain, kidney, liver, bone, or hormone-related health issues.
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I have a specific knee condition like arthritis or CPPD.
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I have had a joint infection in my knee.
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I have not been on a stable dose of NSAIDs for 4 weeks.
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I need X-rays due to major issues with my body's alignment.
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My knee locks, catches, or suddenly gives way.
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I currently use tobacco or nicotine products.
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My knee's shape is unusual due to a birth defect or injury, affecting treatment.
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My knee arthritis is graded from mild to severe.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Events
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SVF (Stromal Vascular Fraction) GroupExperimental Treatment1 Intervention
Subjects with knee osteoarthritis (OA) will receive Autologous Adipose-Derived SVF (Stromal Vascular Fraction) cells
Group II: Placebo GroupPlacebo Group1 Intervention
Subjects with knee osteoarthritis (OA) will be treated with a placebo
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,343 Previous Clinical Trials
3,062,322 Total Patients Enrolled
31 Trials studying Osteoarthritis
3,081 Patients Enrolled for Osteoarthritis
Shane A ShapiroPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
1 Trials studying Osteoarthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Group
- Group 2: SVF (Stromal Vascular Fraction) Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
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