Regenerative Medicine FAQs

This is a newer area of medicine that can be a component of all medical specialties. When treatment addresses bones, muscles, tendons, ligaments, cartilage, or joint problems it is often referred to as Othobiologics. Treatment generally utilizes tissue from the individual [ie your own blood to make platelet rich plasma (PRP) to treat your tennis or golfer’s elbow]. There is also focus identifying the root cause that caused the issue to develop such as abnormal motion (strength and/or flexibility) to facilitate recovery and prevent recurrence.

Both start with gathering information of the patient’s complaints, performing a physical examination and determining a diagnosis or explanation. The difference is how they approach the diagnosis with regenerative medicine trying to normalize structure, function, and facilitate the body’s self repair mechanism. Orthopedic treatment is generally less focused on conservative treatment and tries to maximize recovery with surgical interventions.

A physician who focus is regenerative medicine will evaluate for the best treatment, which could be a referral for surgical intervention. However, there are many alternative treatment directions with the goal to help the patients to heal and avoid any surgical intervention. The goal of regenerative medicine is not necessarily to delay surgical intervention, but to avoid.

Bone: dying bone (avascular necrosis or osteonecrosis) and bone marrow edema (AKA bone marrow lesions/BML)

cartilage: joint arthritis, meniscal tears

Ligament: sprains

muscle/Tendon: strains, rotator cuff tears, golfer’s elbow, tennis elbow, deQuervains, hip “bursitis”, iliotibial band syndrome, patellar tendinopathy, pes anserine tendinosis, Achilles tendinopathy, plantar fasciitis, hamstring tear, muscle pull

Nerve: carpal tunnel syndrome, cubital tunnel syndrome, tarsal tunnel syndrome, foot neuroma

If you have a problem with your bone, muscle, tendon, ligament, joint, cartilage, there may be a viable alternative to surgical intervention or a regenerative medicine treatment may facilitate your conservative treatment and speed recovery.

Through a detailed evaluation during which a history, imaging review and current pathology will be reviewed.

Although the research has been limited, there is data to demonstrate benefit from PRP for muscle and tendon abnormalities and lesser degrees of joint arthritis. Shockwave is an acoustic energy treatment that can facilitate recovery of delayed fracture healing, dying bone (AVN or osteonecrosis), or treat tendon problems. There is less data on using your own fat or bone marrow and these are usually reserved for more severe problems (ie moderate to severe joint arthritis, medium to large tendon tears). The date is quite limited on stem cells due to expense and regulations.

Generally, the earliest results are seen at 3-4 weeks after the procedure with a minority people that may not see initial improvement until 6-8 weeks. Most individuals resolved or plateau their response at 12-14 weeks after treatment.

The goal with regenerative treatments are to address the patient’s underlying problem and determine what caused it to prevent recurrence and need for repeat treatments. However, there are chronic problems such as arthritis. The durability of response can be one year with PRP for knee arthritis that is more severe or potential of >7 years with using once fatter bone marrow for more severe problems.

Regenerative treatments are the practice of medicine governed by the each State’s Board of Medical Examiners. The FDA does not have purview over the practice of medicine. However, the FDA does regulate some tissues and products it classifies as drugs. The FDA also regulates some of the devices utilized for providing the treatments. The general device approvals are for safety and not indication or effect.

In general regenerative medicine is not covered by insurance. However, there are some Worker’s Compensation providers that see the benefit in facilitating recovery of their employees to return to work and may cover the treatment.

Cost has great ranges depending on the type of treatment, provider’s expertise, adjuvant treatments, anesthesia beyond local, number of issues treated, and region of the country.

Prolotherapy/Prolozone: $150-$600 (depending on region and number of injections)

Platelet rich plasma (PRP): $1000-2000/region

Shockwave: $175-250/session

Microfragmented adipose tissue (MFAT): $3000-5000

Bone Marrow Aspirate Concentrate (BMAC): $3000-5000

Culture Expanded Stem Cells (from you – autologous): $15,000-50,000

Treatments may also include guidance with x-ray or ultrasound, laughing gas, in office pain medication, presence of an anesthesiologist, laser, red light, pre-or post-injections, nerve blocks, hyperbaric oxygen treatment, therapy, etc. These may be included or offered as additional services depending on one’s diagnosis.

There are very few “stem cell” procedures for orthopedic issues performed in the United States despite many people stating they provide or received a stem cell treatment that was really a cellular treatment. There are more stem cells in fat/adipose as opposed to bone marrow aspirate. However, there are multiple additional cells included in each of these products that likely contributed to the clinical effect and the outcome felt by the patient. There is a lack of data to directly correlate the number of stem cells to benefit for orthopedic problems.

Instead of considering chronological age it is better to think about biological age. This means there are healthy 90 year-olds that respond well to regenerative medicine and there are sick or unhealthy “young” individuals with multiple medical problems and on multiple medications that may not respond as well.

PRP stands for platelet rich plasma. Blood is obtained from an individual with a routine blood draw and then separated into layers. The heavy red blood cells that carry oxygen are on the bottom with the water/plasma layer on top sandwiching the platelets in the middle. The platelets are then collected and concentrated above the normal number circulating to be used in a small volume to treat a particular problem.

Platelet rich plasma

Platelets are in the blood and activate when you get injured such as a cut to stop the bleeding. When the activate, they release growth factors that stimulate and modulate healing and recovery. PRP treatment for soft tissues such as muscles, tendons, cartilage is obtaining a large number platelets to place in the injured area so that a large magnitude of growth factors can facilitate healing.

PRP is generally used when people have continued symptoms 6 weeks after injury or in chronic problems.

The patient’s own blood

Yes

PRP has the most success at treating mild to moderate muscle, tendon, or ligament problems such as strains, sprains, or mild joint arthritis. Some of the well-known tendon problems are rotator cuff tendinopathy, golfers elbow, tennis elbow, jumpers knee, Achilles tendinopathy, and plantar fasciitis. PRP also can be modified to be anti-inflammatory and used as a substitute for spine epidural injections for pinched nerves or even address pain from a disc.

It is most effective in mild to mild-moderate degeneration.

The greatest evidence for PRP use is for tendon problems. However, if the tenant has a large tear this may require a different treatment such as use of one’s fat.

He asked if there is a partial tear. If the ligament is completely separated, this would likely require surgery

PRP is less likely to treat a acute meniscal tear that would be more responsive to MFAT/BMAC. Chronic meniscal degeneration that may have tears is a component of knee arthritis and if the joint degeneration is not severe can benefit from PRP.

Shoulder pain can come from the ball and socket joint for small joint on top of the shoulder and if the arthritis is mild to mild-moderate can be effective. If the pain is arising from rotator cuff problems, PRP can be beneficial. However, if the tear is large it may require other options such as MFAT/BMAC. If the tendon is completely separated, it may require surgical intervention. If the pain is arising from the labrum, this generally would require a different treatment such as MFAT/BMAC.

Hip pain can arise from multiple areas. People responded well to PRP for “hip bursitis” and iliotibial band (ITB) syndrome as well as other tendons around the joint. If the pain is arising from the labrum, this generally would require a different treatment such as MFAT/BMAC.

Ball and socket hip arthritis respond least well to regenerative medicine and generally has limited response to PRP.

Back pain can arise from 3 major regions. Common low back pain without referral that has had no identifiable source is generally from chronic ligament dysfunction and can respond very well to a specific protocol performed under imaging.

PRP can also be an option to corticosteroid (steroid) epidural injections to address a pinched nerve (radiculopathy).

There are small joints in the back called facet joints and if these are the source of pain the joints and surrounding supporting ligaments can be injected with PRP.

PRP is also effective for sacroiliac joint pain.

Pain from the disc is difficult to conclusively diagnose and is mainly from exclusion. PRP is been shown to be of benefit for disk mediated pain.

The administration or injection of PRP can be painful due to the fluid being placed in a confined space such as a degenerative joint and less painful if the treated tissue can expand. Generally, the pain flare lasts 5-15 minutes and can be reduced with post procedure heat or laser. People generally do not need pain medication after procedure. There are a minority of patients who have a flair the last longer and is generally not concerning unless there are signs of infection.

The total PRP procedure can take over an hour as it includes confirming the problem and procedure, completing paperwork, a routine blood draw, processing the blood, setting up the procedure area and guidance, patient positioning, and monitoring after the procedure. However, the actual PRP injection only takes 5-15 minutes depending on region and number of injections.

There may be a preprocedure local anesthetic placed. Most problems can be addressed with 1-3 injection sites.

The earliest individuals generally notice the onset of improvement is 3-4 weeks with a minority of individuals not seeing benefit until 6-8 weeks.

After the initial procedure pain flare has subsided, there may be some mild increased discomfort compared to before the procedure that may last 12-48 hours. Patients generally return to their preprocedure status in 2-3 days. There can be some minor swelling in the region injected as well as some black and blue where the blood was taken or PRP performed.

If there is a post procedure pain flare it generally resolves within 15 minutes with minor discomfort above usual for 2-3 days. The initial benefit felt as early as 3-4 weeks with resolution or plateau of improvement at 12-14 weeks.

Relative rest for a day followed by normal activities until the procedure pain flare has subsided, if it occurs. Some individuals have low levels of activity before the procedure and are not restricted while others include many athletic activities and are advised to reduce intensity and duration by 50% for 6 weeks. These recommendations are generally targeted to the treatment area with minimal restrictions to other areas. This would be an individualized recommendation.

Nonsteroidal anti-inflammatory medications such as Motrin, Aleve, Advil, ibuprofen, Naprosyn are to be strictly avoided. These anti-inflammatory should be stopped at least a week before the procedure as they can increase the risk of bleeding and not used after the procedure for 6-8 weeks as they can impact recovery. We found no issues with nonpharmaceutical anti-inflammatories such as curcumin, bromelain, Boswellia, tart cherry, arnica, etc. these are not restricted.

There are some medications that can be discussed an individual basis as they demonstrated some negative effects in nonclinical research and the potential negative effects on treatment are unknown. These would include cholesterol lowering medications (ie Lipitor), certain blood pressure medications (ACE/ARB inhibitors), or certain stomach acid medications (ie Prilosec, Prevacid, Nexium).

PRP can cause procedurally related pain, pain flare, or black and blue.

The risks of PRP include a nerve or vessel issue or black and blue with a routine blood draw in the arm or at the injection site. There can be an allergic reaction to the local anesthetic or topical cleaning solution, which is generally the only foreign substances used.

Other treatments can complement the PRP such as shockwave, pre-injections to stimulate healing, laser, peptides, and hyperbaric oxygen treatment.

PRP should not be an isolated treatment and the patient may require additional problems to be addressed such as nutrition to reduce inflammation, weight loss, exercise technique, movement patterns that may but the patient risk of reinjury or be the reason for developing the initial problem.

PRP is stimulating healing and may take longer to see the therapeutic benefit while cortisone can be in “quick fix” the generally is temporary with recurrence of symptoms and can have negative effects on the tissue leading to more persistent problem

PRP comes from the patient being treated while hyaluronic acid comes from the pharmaceutical industry. PRP is generally not covered by insurance while hyaluronic acid (viscosupplementation) is generally covered by insurance for the knee. There is some research data that demonstrates hyaluronic acid complementing PRP treatment. This is usually staged with hyaluronic acid performed prior to PRP.

PRP comes from one’s blood that has 3 major components: water/plasma, red blood cells that carry oxygen, and the platelets. The platelets care growth factors and are concentrated for the PRP treatment. This treatment can be performed on the same day.

Stem cells can come from your own body. With this process, fat or bone marrow is obtained and sent to a lab to process and grow. This generally takes 8 weeks for product to be used in treatment. This can be performed in the United States under the Right To Try Act (2018).

Stem cells from someone else generally cannot be used in the United States and carry greater risks.