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SVF Cell Therapy for Rotator Cuff Tears
Study Summary
This trial will determine if the use of stromal vascular fraction cells (SVFCs) from subcutaneous adipose tissue can improve outcomes for patients undergoing surgical repair of a torn supraspinatus rotator cuff.
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 a severe shoulder tendon tear not retracted more than 3 cm.I have had a serious injury or fracture in my arm.My BMI is either below 20 or above 35.Your total cholesterol level is very high, at 240mg/dL or more.I have diabetes or my A1C level is above 6.5.I have a significant medical condition or orthopedic disability.I have had abdominal liposuction or major open abdominal surgery before.I have had cancer in the past.I have an autoimmune disorder or am HIV positive.You use nicotine products.I do not speak English.I am either male or female.I am between 45 and 65 years old.You are allergic to lidocaine.I still have pain and can't move well after 6 weeks of physical therapy.I have enough belly fat for a minor fat removal procedure.You need to have standard blood tests done and the results must be normal.I have had surgery to repair my rotator cuff before.My MRI shows minimal to moderate fatty muscle changes.I am a premenopausal woman not using birth control.Your MRI shows severe fat accumulation in the muscles.My shoulder MRI shows clear signs of arthritis.I have a tear in a shoulder tendon, but it's not the supraspinatus.
- Group 1: Placebo
- Group 2: Cell Therapy
- 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
How can I join this research project?
"The ideal candidate for this clinical trial would be between 45-65 years of age with some form of muscle tissue. Right now, the study is looking to recruit 56 patients in total."
Are patients currently being accepted into this trial program?
"The clinical trial is still recruiting patients, as of the 27th of July in 2022, and was originally posted on the 1st of July in 2019."
Are geriatric patients being considered for this research?
"In order to be eligible for this clinical trial, applicants must between the ages of 45 and 65. This specific trial has 59 child participants and 249 senior citizens enrolled."
Is Cell Therapy a dangerous medical treatment?
"Cell Therapy's safety was given a score of 2 by our team because, although there is data supporting safety, cell therapy has not yet been proven effective."
How competitive is this study in terms of participant selection?
"That is correct. The study's information page on clinicaltrials.gov says that it is currently looking for 56 individuals to take part in the trial at 1 location."
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