Frequently Asked Questions
Orthobiologic Therapy FAQs
There may be some pressure at the injection site, but the process is fairly quick. You will be giving a numbing agent to help maintain comfort during your treatment. Most patients say that the marrow draw was quite tolerable and would do it again. Here are a couple of our patients talking about the procedure:
- severity and extent of your medical condition;
- how long you have had this problem;
- number of joints/areas that need to be treated; and,
- how many types of cells are necessary to achieve the results you desire.
While the bone marrow draw only takes a few minutes, the total procedure may take up to 2 to 3 hours.
We know that larger numbers of cells do not translate into greater success. In 2012, a biologics company called Osiris presented evidence at the American Academy of Orthopedic Surgery that when 50 million cultured stem 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. A 2016 study showed that patients injected with 25 million had a positive outcome, while those injected with 50,75 or 150 million cells showed little response.
A lot of people are concerned about the reliability and safety of Orthobiologic procedures. Orthobiologic cell therapy is safe since your own cells are used. This minimizes the risk of problems or complications.
You will be sore and stiff after the injection which will last for a few days after treatment. After the numbness wears off, refrain from any activities that increase your discomfort, and refrain from taking anti-inflammatory medications for at least two weeks after treatment. Control your pain with acetaminophen (Tylenol) or medications that your doctor prescribes. Use ice for up to 20 minutes at a time every two to three hours.
Resume physical therapy regimen about 1 -2 weeks after treatment. Your recovery time will depend on the specific condition that is being treated. In all cases, the treatment will need time to be effective. You should notice a gradual improvement in your level of discomfort, and an increase in your range of motion.
- Patients with active cancers and/or infections.
- Patient with severe anemia or other blood problems.
- If bone marrow cells are to be utilized and a patient had a history of a bone marrow derived type of cancer (i.e. lymphoma), this would be considered a relative contra-indication. However, many times those patients can utilize PRP injections but the ultimate decision maker should be their oncologist.
Do not take over-the-counter medications that can thin your blood (aspirin, Motrin, Aleve Advil, Naproxen, etc.). Drink as much water as possible on the day of your injection. Arrange for someone to drive you home after treatment.
- Reduce pain, even chronic joint pain,
- Increase functionality, range of motion, flexibility and sleep quality
- Reduce muscle compensations and risk for future injuries
- Significantly delay or even eliminate the need for more aggressive treatments such as long-term medication or surgery
Patients may see a significant improvement in their symptoms. This may eliminate the need for more aggressive treatments such as long term medication or surgery or joint replacement, as well as a potential remarkable return of function.
Quite often we can, for a nominal cost.
After we inject cells, they go to work right away. They may continue the repair process for up to 1 year or longer. This does not mean that you have to wait for a year for pain relief. Typically patients feel pain relief in the first few weeks to months.
Certainly. None of our procedures impact your options to have surgery in the future, although we hope that won’t be needed.
You can return to most of your normal activities relatively quickly. Depending on where the cells were injected, you may feel some soreness or stiffness. Most patients have no difficulty returning to work within a week or 2.
Regenerative Medicine FAQs
Stem cells are “unspecialized” cells that can develop into another type of cell that is required to repair or replace damaged tissue. They are the body’s “repairmen.” We all have stem cells because our own cells are continually dying and being replaced with new cells. Stem cells are present in bone, fat and blood, but are concentrated mostly in the bone marrow, where blood cells are made. Bone marrow (hematopoietic) stem cells usually develop to form whole blood – red blood cells, white blood cells and platelets. However, in other parts of the body, when exposed to the right growth factors and signaled by neighboring cells, these stem cells can develop into other cells, such as bone, cartilage, tendon and ligaments and therefore, can “regenerate” body tissue. They can also reproduce to make more stem cells for more even healing.
Yes, according to a recent study1 “it is feasible to obtain large numbers of high-quality autologous (your own) MSCs (Mesenchymal Stem Cells) from the elderly population.”
1. Restoring the quantity and quality of elderly human mesenchymal stem cells for autologous cell-based therapies. Block TJ, Marinkovic M, Tran ON, Gonzalez AO, Marshall A, Dean DD, Chen XD, Stem Cell Res Ther. 2017 Oct 27;8(1):239. doi: 10.1186/s13287-017-0688-x. Link to Article
Autologous Stem Cells are your own stem cells and allowed by the FDA under Section 361.
Allogeneic Stem Cells are stem cells from another human being. They are severely restricted by the FDA and must go through a complex costly Section 351 “cell drug” registration. Currently, there are no live FDA approved Umbilical Cord or Amniotic or Placental stem cell products.
Regulatory and FDA FAQs
All of our procedures are allowed under Section 361 of the Public Health Service Act and the same day surgical exception. Section 361 criteria are as follows:
No. The quick summary is: Using live cord or live amniotic stem cells from another person or placenta is considered a cell-drug by the FDA and requires a full drug approval process. There are a few very FDA approved live stem cell products and these are only allowed for restricted use such as for bone marrow transplantation in severe end-stage cancer etc. The full list of approved products are here. None of these approved live cell products are allowed for orthopedic use.
The longer explanation is here: Live stem cells are allowed by the FDA under 2 registrations: Sections 351 and 361 of the Public Health Service Act which provides the authority for FDA to establish regulatory requirements for marketing traditional biologics and human cells, tissues, and cellular and tissue-based products. These two pathways differ markedly in terms of the time, effort and expense required to bring these products to market in the U.S.
One is the simple 361 exemption, and the other is the complex 351 cell-drug approval. All of the orthopedic amniotic and cord products on the market today have the simple 361 exemption, which, unlike a drug approval, requires no clinical trials or data.
What determines if the 351 cell-drug approval is needed? The claim of live cells. The FDA regulation says at 21 CFR 1271.1 at section 4 part 2 that if you claim that your cells are alive and have metabolic activity and they’re a donor tissue (from one person to another) that’s considered a drug so can’t go through the 361 tissue-registration system. It requires a 351 cell drug designation for FDA approval. Also, note that it’s simply the claim that makes the difference. The cells may really be dead and all that exists is the manufacturer claiming that they’re alive, but the claim is enough to trigger the regulation.
So why aren’t these companies following FDA stem cell regulations and just getting the proper 351 FDA approval for their live cord and live amniotic cells instead of playing word games with their marketing? The 351 cell-drug designation is a long, complex, and extremely expensive process. It can take hundreds of millions of dollars and 5–10 years of clinical trials to get a real FDA approval. If their product fails clinical tests they won’t get approval. So the simple online 361 tissue registration and clever wording is a better fit to their bottom line. The upshot? There is no FDA approved live amniotic or live cord blood product with an orthopedic indication on the market today. So if a chiropractor, doctor or sales rep tells you that they have one, beware, it’s not true.
The claim of live cells. The FDA regulation says at 21 CFR 1271.1 at section 4 part 2 that if you claim that your cells are alive and have metabolic activity and they’re a donor tissue (from one person to another) that’s considered a drug so can’t go through the 361 tissue-registration system. It requires a 351 cell drug designation for FDA approval.
Note that it’s simply the claim of live cells that makes the difference. The cells may really be dead and all that exists is the manufacturer claiming that they’re alive, but the claim is enough to trigger the regulation.
We do not offer any exosome or live cord products since they are not approved by the FDA. We only offer autologous products which we offer within the FDA Section 361 guidelines.
Exosomes are a product of lab cultured mesenchymal stem cells. According to recent FDA correspondence exosome, secretome, or Amniosome products are 351 biologics and need a full 351 cell drug registration.
No exosomes, amniosomes, secretomes or exosome products have current FDA approval.
The 351 cell-drug designation is a long, complex, and extremely expensive process. It can take hundreds of millions of dollars and 5–10 years of clinical trials to get a real FDA approval. If their product fails clinical tests they won’t get approval. So the simple online 361 tissue registration and clever wording is a better fit to their bottom line.
The upshot? There is no FDA approved live amniotic or live cord blood product with an orthopedic indication on the market today. So if a chiropractor, doctor or sales rep tells you that they have one, beware, it’s not true.
All of our procedures are allowed under Section 361 of the Public Health Service Act or the same day surgical exception, so we don’t need a new drug application. Section 361 criteria are as follows:
All new drugs that are licensed by the FDA go through an FDA application process called an IND which stands for Investigational New Drug Application or an NDA which stands for New Drug Application. Since our procedures fall under Section 361 and/or the same day surgical exception, we do not need to register them as a new drug and so we do not need an FDA drug application (IND or NDA.)
Conditions and Diseases FAQs
We treat the following conditions:
HIP / THIGH PAIN
ANKLE / FOOT PAIN
SPINE / BACK PAIN
TENDON / MUSCLE PAIN
WRIST / HAND PAIN
We only treat orthopedic joint, muscle and tendon problems where we feel that the medical studies are solid and compelling and within FDA regulations and guidelines.
We do not treat:
- Systemic conditions such as COPD, stroke, heart disease, Parkinson’s disease, multiple sclerosis, lyme disease etc.
- Patients with active cancers and/or infections.
- Patient with severe anemia or other blood problems.
If bone marrow cells are to be utilized and a patient had a history of a bone marrow derived type of cancer (i.e. lymphoma), this would be considered a relative contra-indication. However, many times those patients can utilize PRP injections but the ultimate decision maker should be their oncologist.
ENJOY LIFE AGAIN WITHOUT JOINT PAIN OR SURGERY
Find out if you are eligible for our treatments.
Is Orthobiological Cell Treatment Right For You?
Although Orthobiologic Treatments are considered by some people to be experimental, various research studies show that cellular therapy and platelet rich plasma injections may provide excellent relief from joint and musculoskeletal pain and ongoing inflammation.