Healing Rotator Cuff Tears Without Surgery

Our clinic, in collaboration with the Orthobiologics Research Initiative (ORI), is conducting a clinical study on a new non-surgical treatment for partial rotator cuff tears. We are evaluating Micro-Fragmented Adipose Tissue (MFAT) injections – using a patient’s own processed fat tissue – to promote healing of the rotator cuff tendon. This investigational therapy aims to reduce shoulder pain and improve function without the need for invasive surgery.

Partial rotator cuff tears are a common shoulder injury in active and older adults, often causing significant pain and limiting arm movement. Traditionally, serious rotator cuff injuries might be treated with surgery, which can involve a lengthy recovery, risk of re-injury or complications, and high out-of-pocket costs. Cortisone (steroid) injections are sometimes used to manage pain when surgery is not appropriate, but repeated steroid shots can weaken the tendon and increase the chance of a larger tear requiring surgery. That’s why our team is exploring a regenerative, non-surgical approach using MFAT.

What is MFAT?

Micro-Fragmented Adipose Tissue therapy takes a small sample of your own fat cells (for example, from the belly), gently “washes” and filters them, and then injects them into the injured rotator cuff area to encourage tissue repair. This procedure is performed in a single outpatient visit under local anesthesia. The MFAT injection is guided by ultrasound imaging for precise placement into the rotator cuff tear. The goal is to harness your body’s natural healing cells to repair the tendon damage. The MFAT procedure has been authorized by the FDA as a safe (minimal-risk) treatment, though it is still considered experimental for rotator cuff injuries.

About the Study

This is a single-blind, randomized controlled trial. We plan to enroll 60 patients with qualifying partial rotator cuff tears. Participants are randomly assigned to one of two groups: one group will receive the MFAT injection, and the other group will receive a standard cortisone injection (acting as a control). For every 3 patients, 2 will receive MFAT and 1 will receive cortisone. Neither you nor the physician will know which treatment you received until after the study is completed (to keep the results unbiased). All injections are done under ultrasound guidance by an experienced physician.

Timeline – What to Expect:

If you qualify and decide to participate, your total time in the study will be about 12 months. Here’s an overview of the participant experience:

• Screening: Our research team will first confirm if you are eligible through an initial screening visit and review of your shoulder MRI and history.
• Treatment Visit: If you’re eligible, you will undergo the treatment procedure. This includes a minimally invasive fat harvest (about 3 tablespoons of fat taken from your abdomen or flank) under local anesthetic. The fat is processed into the MFAT product right away. You will then receive an injection into your shoulder – either the MFAT into the rotator cuff tendon or a cortisone injection, depending on your group (you won’t be told which one). The procedure is done in our clinic procedure room. You will be awake (with local numbing and light medication if needed) and can go home the same day after a short monitoring period. Most patients are observed for a couple of hours and must meet standard discharge criteria (alert, managing pain, no dizziness or nausea) before leaving.
• After the Injection: For the first 3-5 days, you may use a sling for comfort (not required) and then begin gentle physical therapy as recommended. We ask that you avoid strenuous overhead activities or heavy lifting for about 4 weeks after the injection to protect your shoulder as it starts healing. Our team will let you know when it’s OK to resume normal activities.
• Follow-Up Visits: You will be closely followed by our research staff for one year. We will check in at 1, 3, 6, 9, and 12 months after the treatment. At these follow-up points, you will complete short questionnaires about your shoulder pain and function (for example, rating your pain and ability to do daily activities). These can be done at the clinic or via our secure online system. You will also have a repeat MRI 12 months after the injection to see how the tendon looks compared to before. All patients are followed for the full 12 months, even if symptoms improve or worsen, so we can accurately assess outcomes.
• Cost: There is no cost to you to participate. The study is funded by the Maryland Stem Cell Research Fund, and all study-related care is covered – including doctor visits, the procedure itself, and the MRI scans. You will not be billed for any treatments or imaging that are part of the research study. We also do not bill your insurance for these research-specific procedures. (Any unrelated medical care you receive outside of the study would still be your responsibility as usual.)

Throughout the trial, you will continue to receive care from our medical team. You are free to withdraw from the study at any time. If you decide not to participate or to leave the study early, it will not affect your regular medical care – you can still pursue other treatments as you and your doctor see fit. Our goal is to make this experience as comfortable and informative as possible, while gathering important data on this new therapy.

Why Non-Surgical?

Choosing a non-surgical treatment approach for rotator cuff tears can offer several advantages. Surgery (even arthroscopic “minimally invasive” surgery) still involves making incisions, repairing or trimming tendon tissue, and a lengthy rehabilitation afterward. Patients who undergo rotator cuff repair surgery often face 6 months or more of recovery time and physical therapy, and there are inherent surgical risks such as infection, nerve injury, anesthesia complications, or even hospital-related problems in older patients. Research has shown that shoulder surgeries carry a small but real risk of serious complications – for example, one large analysis reported about a 0.5% risk of major complications (and a 0.04% risk of mortality) from elective rotator cuff surgery. While those risks are relatively low, they are not zero.

By contrast, injection-based therapies like MFAT are outpatient procedures that avoid general anesthesia and incisions. Using your own tissue (fat) for healing also avoids introducing any foreign materials. In fact, a multi-center study of over 1,100 patients who received MFAT injections for orthopedic conditions found no serious adverse effects related to the treatment or the fat harvesting procedure. This suggests that the safety profile of MFAT injections is excellent. Avoiding surgery also means a much faster return to daily activities – typically days or weeks of moderate activity restriction instead of months of post-surgical limitations.

Another reason we pursue a non-surgical option is that corticosteroid injections, while commonly offered for shoulder pain, do not help the tendon heal. Steroids may temporarily reduce inflammation and pain, but they can also impair tendon tissue quality. Studies indicate that steroid injections in the shoulder can be associated with a higher risk of rotator cuff tear progression and even higher re-tear rates after surgical repair. In other words, repeated steroid use might relieve pain in the short term but could make the underlying damage worse over time.

MFAT provides a biological solution: The fat tissue from your body contains cells that secrete growth factors and anti-inflammatory signals to encourage healing. When we inject MFAT into a partial tear, the goal is to boost the tendon’s natural repair process – something steroids cannot do. This therapy essentially uses your body’s own healing cells to potentially strengthen and mend the injured rotator cuff, rather than just masking the pain.

In summary, a non-surgical approach like an MFAT injection may offer less risk, less downtime, and a way to actually heal the tendon. For many patients, avoiding major surgery is a huge benefit in terms of comfort and convenience. Our study is designed to see if this novel treatment can truly bridge the gap between basic treatments (like physical therapy or steroid shots) and major surgery, giving patients a much-needed alternative for rotator cuff injuries.

Who Can Participate?

We are looking for adult patients with partial rotator cuff tears who meet certain criteria. Every potential participant will undergo a thorough screening to ensure the study is appropriate and safe for them. Below is a general overview of the eligibility criteria.

You may be eligible for this study if you:

• Are an adult, age 18 or older.
• Have a documented partial-thickness rotator cuff tear. This means the tendon is damaged but not completely torn off. Typically, this is confirmed by an MRI and a clinical exam by a doctor.
• Have ongoing shoulder pain and limited shoulder function due to the tear. (During screening, we use pain and disability questionnaires to quantify this. Moderate levels of pain and difficulty with movement are required – essentially, your tear is causing problems that merit treatment.)
• Have tried conservative treatments without sufficient relief. For example, you may have done physical therapy for at least a month or more, and/or tried oral pain medications, but still have significant symptoms. We want to ensure that simple measures haven’t worked for you before trying this experimental therapy.
• Are generally healthy enough for a minor procedure. You should not have uncontrolled chronic diseases that would make an injection unsafe. You must also be able to temporarily stop certain medications (like anti-inflammatories) around the time of the procedure – our team will review your medication list.
• Can attend follow-up visits for a year. This includes coming in for the injection and returning for check-ups/MRIs, or completing follow-up surveys. Commitment to the full 12-month follow-up schedule is important for the integrity of the research.
• Speak and understand English. (The study questionnaires and instructions are in English, so this is for safety and data accuracy.)

You would NOT be eligible if any of the following apply to you:

• Full-thickness rotator cuff tear. If your rotator cuff is completely torn (often this requires surgical repair rather than an injection), you would not qualify. Our study is only for partial tears.
• Severely overweight. The study excludes individuals with a body mass index (BMI) greater than 35, as higher BMI can increase risks in the fat harvest procedure and may affect healing.
• Certain chronic illnesses: We cannot include those with active autoimmune diseases (for example, rheumatoid arthritis or psoriatic arthritis affecting the shoulder). Uncontrolled diabetes or other severe systemic conditions may also disqualify you. Additionally, if you have significant shoulder arthritis or other shoulder pathology that is the main source of your pain (e.g. advanced osteoarthritis, severe bone spur causing impingement, or large cartilage lesions), you may not be eligible. We need to be sure that a partial tear is the primary issue.
• Recent shoulder treatments: If you’ve had a corticosteroid injection in the affected shoulder within the last 3 months, or any shoulder surgery within the last 6 months, we will need to wait beyond those time frames before you can join. Prior shoulder surgery that was recent or healing could interfere with results.
• Active infection or wound: Any infection in your shoulder, or a systemic infection, would make participation unsafe. We also cannot enroll anyone with a current infection at the site where we would take the fat (abdomen or thigh).
• Allergy to materials used: If you have a known allergy to local anesthetics (like lidocaine) or to the materials used in the process (for example, certain antibiotics or solutions used to process the fat), let us know – this could be an exclusion. We will review all allergies in screening.
• Pregnant or breastfeeding: For safety, pregnant women or mothers nursing a baby are not eligible for this study. The effects of the procedure on a fetus or infant are not known, so we err on the side of caution. Women of childbearing potential will have a pregnancy test during screening and before the injection to confirm they are not pregnant.
• Recent or active cancer in the area: If you have a history of shoulder-area cancer, or have had chemotherapy/radiation involving the shoulder, unfortunately you would not be able to participate. Similarly, any bone tumors or other malignancies involving the shoulder are exclusions.
• Bleeding disorders: Because the procedure involves a minor “lipoaspiration” (fat draw) and an injection, if you have a clotting disorder or are on strong blood thinners (anticoagulants) that can’t be paused, you may be excluded to reduce risk of bleeding. We will discuss this during screening.
• Other conditions: There may be other medical factors that the study doctors determine would make participation unsafe or data difficult to interpret (for example, severe neck problems that cause shoulder symptoms, or being in an active lawsuit related to your shoulder). Our team will review your health history thoroughly to ensure the trial is appropriate for you.

Note: The lists above are not exhaustive. If you’re not sure whether you qualify, we encourage you to reach out to our research team. We will perform a detailed assessment of your case. The basic idea is that we are seeking patients who truly have a partial rotator cuff injury that hasn’t been fixed by standard treatments, and who are otherwise healthy enough for an injection procedure.

Informed Consent

Before joining the trial, you will be given a comprehensive Informed Consent Form to read and sign. This form explains, in plain language, the study’s purpose, procedures, potential risks, benefits, and your rights as a participant. We want you to fully understand what participation involves. Click here to view the Informed Consent Form (PDF) ahead of time, so you can review it at your own pace.

Please take your time to read this document. It will tell you about the treatments being studied (MFAT vs. cortisone), the number of visits, what is expected of you, and all known side effects or risks. For example, the form discusses possible procedure risks like temporary soreness at the fat harvest site, shoulder stiffness, or rare complications like infection or bleeding. It also explains that your participation is voluntary – you can decide not to join, or withdraw at any time, and it will not affect your regular medical care. We will go over this consent form with you in person, answering any questions, before anything is done. Only when you feel comfortable and all your questions have been answered will we ask for your written consent to proceed.

Being in a research study is a partnership – our responsibility is to keep you informed and safe, and your responsibility is to follow the study procedures and communicate with us about how you’re doing. The informed consent process is a key part of that partnership.

Supporting Research

This regenerative medicine study is built on a foundation of scientific research. Below are some of the published studies and findings that support the rationale for using MFAT in rotator cuff injuries:

• Steroid Injections & Tendon Tears: Research suggests that steroid injections, while common for shoulder pain, may contribute to tendon damage. A 2022 study found a positive correlation between receiving steroid injections and subsequently developing rotator cuff tears. In a 2020 review, researchers noted that patients who got cortisone shots prior to rotator cuff surgery had higher re-tear and revision surgery rates later on. These findings caution against relying on steroids as a long-term solution and underscore the need for treatments that help the tendon heal.
• MFAT in Tendon Healing (Preclinical): In laboratory and animal studies, MFAT has shown promising healing effects. For instance, a 2021 study in an ovine (sheep) model of tendon injury demonstrated that injections of micro-fragmented adipose tissue enhanced tendon healing and reduced signs of tendinopathy. This pre-clinical evidence supports the idea that fat-derived cells can repair tendon tissue.
• Small Human Studies on MFAT: Early clinical studies in people have been encouraging. Small pilot studies (on the order of 10–20 patients each) from 2010–2020 investigated MFAT injections for partial rotator cuff tears. They reported that MFAT treatment under ultrasound guidance was safe (no significant complications) and led to improvements in shoulder pain and function in those patients. In one analysis, patients maintained better shoulder function and pain relief at a 2-year follow-up after a single MFAT injection, indicating a potentially lasting benefit.
• Case Report – MFAT for Tough Rotator Cuff Injuries: A published case study by our own lead investigator, Dr. John Ferrell, MD, looked at using MFAT for a rotator cuff injury that wasn’t healing with standard care. The report concluded that MFAT could be a novel approach for treating difficult rotator cuff tears and chronic tendon issues that don’t respond to typical treatments. This personalized evidence from our team helped inspire the design of the larger trial.
• MFAT for Other Shoulder Conditions: Beyond rotator cuff tears, regenerative injections of fat have been studied in related shoulder problems. For example, researchers have used MFAT to treat arthritis in the shoulder joints (both the acromioclavicular joint and the glenohumeral joint) and observed reductions in pain. These positive trends in various shoulder conditions suggest that MFAT’s healing effects are not limited to one type of injury, and they provide a strong scientific rationale for exploring MFAT in rotator cuff tears.
• Safety of Fat Injections: As mentioned, the safety profile of MFAT is a major advantage. In a large study of 1,114 patients treated with liposuctioned, micro-fragmented fat for orthopedic issues, no serious adverse events were reported. This contrasts with the complication rates seen in surgical studies, and gives us confidence that the procedure is reasonably safe when performed correctly. Common minor side effects are typically limited to temporary soreness or bruising at the fat harvest site or injection site.

(For those interested in reading further, references to these studies are available upon request. We are happy to provide more scientific literature to anyone who wants to dive deeper into the research.)

Dr. Ferrell on MFAT – Video Interview

In the video below, Dr. John Ferrell III, MD, the principal investigator of this trial, explains the MFAT treatment and answers common questions about the study. Dr. Ferrell is a nationally recognized expert in regenerative orthopedics and leads the Orthobiologics Research Initiative team. He discusses why he believes MFAT could be a game-changer for rotator cuff injuries, what patients can expect during the trial, and how this research might impact the future of orthopedics.

[Video featuring Dr. Ferrell – coming soon]

(Video will be embedded here once available.)

Interested in Participating?

If you think you might qualify for this study and want to explore enrollment, we encourage you to reach out! Our research staff is ready to discuss the trial with you, answer any questions, and guide you through the next steps. Participation is completely voluntary, and we will make sure you have all the information you need to make an informed decision.

Contact us by filling out the form below or calling our office at (240) 301-9200. We will respond promptly to provide more details and schedule a screening appointment if appropriate.

• Name: [Your Full Name]
• Email: [Your Email Address]
• Phone: [Your Phone Number]
• Message: [Let us know you’re interested in the Rotator Cuff MFAT study and any questions you have]

[Submit]

Thank you for your interest in our Rotator Cuff Regenerative Treatment Study. By considering clinical research, you are contributing to the advancement of new therapies that could help not only yourself but also future patients with similar conditions. We look forward to hearing from you and potentially working together towards healing your shoulder without surgery!