Regenerative Cell-Based Therapy
What are Regenerative Cells?
Regenerative cells are unique cells in our body which have the ability to become many different types of cells. They are our body’s natural repair mechanism when we sustain injuries or develop wear and tear of our joints, such as in arthritis. Our body stores regenerative cells in our bone marrow, fat, and organs, and calls them into action when needed. When we sustain an injury, the injured area releases chemicals which send signals to the regenerative cells to start the repair process. This is how we heal.
As we age our body still has plenty of stored regenerative cells, but may not be able to mobilize them effectively to treat an injured area. This is especially true of areas with restricted blood flow – such as joints.
Are these procedures FDA approved?
It is up to the doctor, not the FDA to decide what treatment is best for you. However, IRM does follow all FDA guidelines which outline how Regenerative Cell procedures should be performed.
How do you get my Regenerative Cells?
We use small needles to remove regenerative cells, including regenerative cells from your hip bone and fat tissue. This is considered a small outpatient procedure. No open surgery is required.
How do you put the Regenerative Cells where I need them?
We use X-Ray and Ultrasound machines to accurately deliver the Regenerative Cells to the injured or degenerated part of your body.
How painful is the procedure to remove my Regenerative Cells and to inject them?
Your doctor will use local anesthetics while your regenerative cells are transferred. Most patients experience minimal pain during the procedure.
How many treatments are needed?
Typically only one Regenerative Cell Treatment is needed. However, we may recommend several more Platelet Rich Plasma injections to help the regenerative cells become more active.
What do you do with my blood or bone marrow to get the Regenerative Cells?
After we remove a small amount of fat or blood, we placed them into a machine called a “Centrifuge” to spin them. This process separates your regenerative cells and from other cells, which are not needed, or could interfere with the success of the procedure. Your bone marrow aspiration yields its concentration of regenerative cells including regenerative cells with the actual draw using a new state of the art needle.
What is Platelet Rich Plasma (PRP)?
Platelet Rich Plasma (PRP) is the part of your blood which contains specific cells, called Platelets. These platelets have several important jobs: 1.They help your body form blood clots when you bleed. 2. They travel to inflamed areas of our body and tell the regenerative cells where to do their work. 3. They contain important growth factors (fertilizers), which help the Regenerative Cells to succeed.
What is the difference between a Regenerative Cell Treatment and PRP?
Regenerative cells, including Regenerative Cells, are removed from your bone marrow (BMAC) or fat (Fat Graft). PRP is a sample of your blood which contains specific cells, called “platelets”. A PRP treatment is sometimes adequate by itself as a treatment of inflamed tendons, ligaments or joints. However, if there is significant degeneration, a Regenerative Cell treatment is usually needed.
How long does it take for Regenerative Cells to work?
After your doctor injects the conglomeration of different regenerative cells and Regenerative Cells where they are needed, they go to work right away. They will continue their repair process for up to 1 year or longer. This does not mean that you have to wait for pain relief. Patients typically feel pain relief in the first few weeks to months.
What is a Bone Marrow Regenerative Cell (BMAC) Procedure?
In a Bone Marrow Regenerative Cell Procedure (BMAC), a new and revolutionary aspirate needle is used to capture a much higher concentration of bone marrow aspirate regenerative cells and other regenerative properties from the bone marrow of our hip bone. These cells were once placed into a machine called a “centrifuge” which “spins” the cells for adequate separation. However, we are convinced that when bone marrow aspirate is centrifuged, you throw away significant aspects of the “bone marrow soup” – the key to our success. Our needle technology guarantees the capture of these concentrated and powerful regenerative cells without centrifugation.
These regenerative cells can then be injected where needed, such as a degenerated knee, hip joint and/or other orthopedic conditions.
What is a Fat Graft or Mini-Liposuction Procedure?
A “Fat Graft” is fat tissue which is removed with needles from your abdomen, hip, or buttock area with a small needle. This is also referred to as a “mini-liposuction” procedure, similar to cosmetic surgery procedures. This Fat Graft contains many useful regenerative cells including Regenerative Cells. These Cells are then injected where your body needs them.
Are these procedures the same as prolotherapy?
No, Prolotherapy is something very different. Prolotherapy injects a sugar-like substance into an inflamed joint. This causes even further inflammation in the hopes that the body will start a repair process. However, prolotherapy is only a short-term treatment and does not use actual Regenerative Cells.
How long have these procedures been done for?
Regenerative Cell procedures have been done safely for the last 20 years. Initially, these procedures were done for cancer patients where regenerative cells from healthy donors were transferred to cancer patients. Over the last 10 years, doctors scientists have discovered that Regenerative Cells can also be taken from one part of a patient’s body and then placed into another area where they are needed.
How many of these procedures have been done?
Dr. Purita administered thousands of PRP and Regenerative Cell procedures, spanning over 12 years.
Can I still have surgery if this procedure fails?
Certainly. None of our procedures would impact on your option to have surgery in the future.
Do I have to take time off work for this procedure?
Our Regenerative Cell procedures takes 3 ½ – 4 hours to complete. So, we do recommend that you take the day off from work. Most patients have no difficulty returning to work the next day but this may vary from patient to patient, depending on their occupation, body part, pain thresh hold and level of discomfort (if any).
Do I need a driver for my procedures?
It is recommended that patients arrange for transportation when coming in for treatments. Our clinic may arrange for this upon request only for your initial regenerative cell procedure.
When do I return to normal activity?
Though some patients may experience discomfort post treatment, you can return to most of your normal activities immediately. Depending on where the Cells were injected, you may feel some transient soreness or stiffness but no physical restrictions are given. We want you to move around!
Are there certain medical conditions which would disqualify me from having a Regenerative Cell procedure?
Yes. If you have an active form of cancer, we do not recommend our procedures. We may also identify other medical conditions which could disqualify you. For this reason, we will review your medical history and let you know if we find a disqualifying condition.
How can you tell if I am a candidate for the procedure?
Our doctors will review your Radiology studies and Medical History to determine if you are a candidate for our procedures. This is followed by a formal patient consultation.
Is anything else added to the regenerative cells before you inject them?
Apart from using your own Regenerative Cells, we also add natural growth factors to help the Regenerative Cells succeed.
Do I need an anesthetic for my procedure?
Typically, local anesthetics alone are adequate to provide pain relief. Sometimes oral sedatives are also given.
How long does the procedure take?
Our most commonly performed procedure, which combines the regenerative cells from your bone marrow (BMAC) and fat with the platelet cells from your blood (PRP) including cytokine therapy takes about 3 ½ – 4 hours to complete.
How quickly can I feel better?
This varies from patient to patient. Most patients feel some benefit in the first weeks after the procedure.
How much downtime is there, after my procedure?
There is no real downtime with this treatment. However, you may experience an “inflammatory phase” for a couple of days after your procedure where the treated body part, may get inflamed with some discomfort, soreness and stiffness. But you should be able to resume normal activities soon after if you are up to it.
Could my body reject the Regenerative Cells?
Since the regenerative cells were taken from your own body the risk of rejection is extraordinarily low.
How often does the procedure work?
The great majority of patients are very happy with their results and would do it again.
I am taking blood thinners. Can I still have the procedure?
Many patients take blood thinners. We will screen them and let you know if you are still a candidate for our procedures.
Do I need any other therapy after my procedure?
Depending on your condition, we may offer other ancillary treatments such as Laser Therapy, PressureWave Therapy or additional PRPs to help the Regenerative Cell process. We may also recommend specific exercises and nutritional supplements.
Can certain supplements help with the success of the Regenerative Cell Treatment?
Yes. We will provide you with our own proprietary supplements to help the Regenerative Cells become as active as possible. This often adds to the success of the procedure.
Where are Regenerative Cells Found?
Regenerative cells can be found in just about any area of our body however, they are most abundant in our bone marrow and fat tissue. These regenerative cell “storage areas” provide a ready source which can be harvested in a simple and safe fashion.
How can Regenerative Cells help joints heal?
Regenerative cells can help repair injured or degenerated tissues in our body. For instance, as cartilage in our joints degenerates and causes orthopedic problems, regenerative cells have the ability to regenerate cartilage, lessening pain and improving function.
How can Regenerative Cells be used?
Doctors can use simple, minimally invasive outpatient procedures to transfer regenerative cells from a patient’s body’s storage sites to areas where they are needed. Regenerative cells can be safely removed from the body’s bone marrow, blood, and fat tissue and delivered to injured or degenerated areas of the body.
How Quickly do Regenerative Cells Start to Work?
While regenerative cells begin the repair process immediately, it may take weeks or months before patients may notice an improvement in their symptoms.
Am I a Candidate to receive Regenerative Cell Therapy?
Regenerative cell therapy is not the best course of treatment for some types of conditions. Please complete our Patient Eligibility Form and one of our Patient Coordinators will contact you shortly.
FDA Compliance: Do We Harvest or Use Embryonic Regenerative Cells?
No. With our present technology, embryonic regenerative cells are not the answer to the orthopedic issues we deal with.
Many facilities outside the United States make use of embryonic regenerative cells, which outside of the United States are easy to procure. The problem with the embryonic regenerative cells are the many complications associated with them. Besides the ethical considerations, from a practical point of view, we are still a long way from being able to utilize these cells in a safe and consistent manner. When using embryonic regenerative cells, you are inheriting any potential diseases that the baby may have. For instance, the baby may have a gene that when past age 50 may cause a tumor. The embryonic cells themselves may act as a tumor since there is no natural check on these cells. Furthermore, these cells are foreign materials to the body, and the body will attack these cells in an immune response. This can sometimes result in a serious medical condition called graft versus host disease. For this reason, the patient may have to be placed on immunosuppressant drugs—much like any other organ transplant patient.
Do We Culture Cells?
No. There are some centers which recommend taking the regenerative cells from the bone marrow, growing them in a laboratory and then injecting them back into a patient, but we do not, as we believe this process is not the best way to achieve repair.
Many studies suggest that once the regenerative cells are manipulated outside the body they lose their effectiveness. Furthermore, there is a suggestion that by reproducing these cells outside the body the genetic makeup of the cells may be altered leading to any number of significant problems. Among other factors, it is believed that the telomeres, or ends of the DNA strands, may be significantly altered. The FDA has ruled that cultured cells cannot be used in the United States. We further know that larger numbers of mesenchymal regenerative cells do not translate into greater success. In 2012, a biologics company, Osiris, presented evidence at the American Academy of Orthopedic Surgery that when 50 million cultured regenerative cells were injected into patients 20% of the patients reported less pain while when 100 million were injected 0% of the patients had less pain.