Regenerative Medicine

What is regenerative medicine?

Regenerative medicine consists of powerful new therapies — such as PRP with or without A2M, biologic cell therapies, and Tenex — that help your body repair and even regenerate damaged tissue to heal the underlying cause of your pain and dysfunction. With the aid of regenerative medicine, your body produces new collagen, elastin, fibrins, and growth factors needed to create stronger, healthier, more resilient skin, tendons, muscles, and cartilage.

What is PRP?

Platelet-rich plasma (PRP) is a concentrated serum made from the healing platelets found in your own blood, plus a small amount of the liquid portion (i.e., plasma) of your blood.  Your doctor creates the serum by withdrawing a small amount of blood from your arm, and spinning it in a sterile centrifuge to isolate the protein- and growth factor-rich platelets.

Your doctor injects the PRP into damaged tissue to promote repair and regeneration in conditions like arthritis and tendinitis. If you have arthritis, you can boost the power of PRP by adding A2M injections.

What are A2M injections?

Alpha- 2 macroglobulin (A2M) is one of the most important proteins in your plasma. It has emerged as a potential treatment that may be able to slow the development of early cartilage damage on in-virto and pre-clinical studies. A2M has strong anti-inflammatory effects, and is a broad spectrum inhibitor of several chemicals that slowly erode cartiliage and neutralize their degenerative effect. After your doctor isolates this protein and injects it into your cartilage, it deactivates proteinases that break down your cartilage cells. If you have arthritis, your doctor advises adding A2M to PRP to preserve the health and mobility of your joint. 

How Effective Is It?

There are a few studies comparing the use of A2M to other injectable treatments in osteoarthitis. A randomized controlled trial performed at NYU with 75 patients compared improvement in function after PRP, A2M and corticosteriod injections. At 3 months, A2M proved statistically significant improvement than PRP or corticosteriod injection. 

How is it prepared?

Similar to PRP, your blood is drawn and spun in a centrifuge. An additional step is performed using a special device to filter the plasma and concentrate the A2M macromolecules. The concentrated A2M is then injected in the arthritic joint. 

When will I see results?

Like most orthobiologic therapies, the average time to see full response is 2-3 months, although many report results sooner. 

What is Hair PRP?

PRP is a regenerative treatment for variety of conditions including hair loss. PRP treament for hair loss uses the patient’s own blood cells to accelerate healing to a specific area.  PRP increases circulation to your hair follicles, improves overall hair density, thickens your hair shaft, reduces excessive hair shedding, and may alleviate inflammation. Since PRP uses your own own blood cells, PRP injections are safe, minimally invasive, has minimal risk and short down time.

What is Biologic Cell therapy?

Your body is composed of differentiated (i.e., specific) cells, such as skin cells and bone cells. But it’s also filled with undifferentiated cells, called stem cells, that can turn into many other types of cells, depending on your body’s needs. 

While many consider this treatment as stem cell therapy to regenerate tissue, we prefer to describe it as biologic cell therapy which aims to harness the natural regenerative ability of tissues by creating a healing environment. Stem cells are immature cells that have the ability to develop into bone, cartilage, muscle, tendon or ligament. We obtain a concentrated mixture of mesenchymal stem cells (MSCs), platelets, interleukins, and growth factors from the patients own body. Most stem cells and concentrated growth factors  are located in your hip bone marrow and in fat.  Your doctor may obtain these via bone marrow aspirate concentrate (BMAC) or via a mini liposuction device called Lipogems. These techniques provide the most potent regenerative serum  which is then injected directly into the area of injury or pain using precise localization with ultrasound or x-ray guidance. 

FDA GUIDELINES

The team at SCORE remains compliant with the 2017 FDA guidelines on 

Regulatory Considerations for Human Cells, Tissues, and Ceullular and Tissue-Based Products: Minimal Manipulation and Homologous Use. All of the procedures performed use 501(k) FDA cleared devices and are consistent with the minimal manipulation and homologous use criteria outline by the FDA. This includes:

•                         Platelet-rich plasma (PRP) and blood products (A2M)
•                         Bone marrow concentrate (BMC, BMAC, stem cells from bone marrow)
•                         Lipogems Fat/Adipose grafts (Micro-fragmented fat, MFAT)
•  

Procedures using these regenerative and orthobiologic products are autologous (from your own body), minimally invasive and treatments are performed consistent with homologous use for orthopedic and sports medicine indications. These orthobiologic procedures are the most studied within the regenerative medicine space. These procedures have not been FDA approved for tendons, ligaments, cartilage, joints, or muscles, but the procedures offered are based on “firm scientific rational and on sound medical evidence” and consistent with FDA guidelines. The use of PRP, BMAC and MFAT have the most safety data behind their use, and are generally considered accepted practices. 

FDA REGENERATIVE MEDICINE CONSUMER ALERT

The recent Consumer Alert is one of many public warnings and letters issued by the FDA over the past few years. The recent letter listed specific regenerative procedures that the FDA notes are unapproved products. SCORE does NOT offer these procedures, including:

•                         stromal vascular fraction (fat-derived cells)
•                         umbilical cord blood and/or cord blood stem cells
•                         amniotic fluid
•                         Wharton’s jelly
•                         Exosomes

Accelerate healing with regenerative medicine at The Spine Center and Orthopedic Rehabilitation of Englewood, PC. Call the friendly office team or use the online form.