“Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-based Products: Minimal Manipulation and Homologous Use”

On November 16, 2017, The FDA posted definitive guidelines concerning what meets minimal manipulation rules and regulations and what is accepted under the practice of medicine guidelines in the specialty of Regenerative Medicine. The FDA further restated the requirement that regenerative medicine be governed by homologous use. As I interpret the guidelines there are winners and losers:

Winners
Physicians who use compliant regenerative therapies:

  • Amniotic fluid without stem cells
  • Blood-derived preparations (e.g., PRP, PPP)
  • Bone marrow aspirate

Losers
Physicians who use non-compliant regenerative therapies:

  • Adipose tissue-derived materials obtained by enzymatic digestion
  • Amniotic fluid with cells Cord blood derived materials (non-autologous treatments)
  • Stem Cell Clinics that advertise about using amniotic fluid as a source of stem cells and regenerative therapy along with those clinics that treat everything from alopecia to ALS to arthritis

You might ask how is that different from the current situation? First of all, the FDA Commissioner has stated in press releases that the FDA is going to go after bad actors. The Cures Act provided for increased funding to the FDA, which we suspect the Commissioner will use in part to go after the bad actors. Also, the FDA wrote in their Guidance on Minimal Manipulation and Homologous Use that “healthcare providers” need to pay attention. We have never seen them explicitly refer to the doctors and clinics providing regenerative medicine. Finally, the FDA indicated that there would be a transition period (3 years) during which manufacturers would need to enter the RMAT program to get their non-compliant products properly approved; or else. And the reason that there could be teeth in the “or else” is that the FDA will get lots of fees from all of the non-compliant products entering the RMAT program.
Last of all, what the FDA did not address as part of consumer protection; but what I incorporate in my daily practice is evidence based intervention.

Now that you are better informed and have an idea as to the laws governing our regenerative medicine marketplace, stay away from the Charlatans and Camp Followers. Then take the next step and ask your physician for the Outcomes Evidence on which a regenerative intervention for your arthritic joint is based before undergoing a procedure. To better understand that evidence call for (312) 475 1893 to set up a consultation

You may watch my webinar by accessing my web site www.ilcellulartherapy.com.

* Minimal Manipulation and Homologous Use

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Regenerative options for patients receiving chemotherapy, immunosuppression or radiation therapy

Regenerative options for patients receiving chemotherapy, immunosuppression or radiation therapy

There has always been a category of patients for whom Bone Marrow Concentrate derived stem cells and growth factors were not a viable option. Patients who have received or are receiving chemotherapy, radiation therapy or immunosuppression have diminished stem cell viability and actual numbers. Such patients have historically been denied cellular orthopedic intervention; at the same time, they are problematic candidates for a joint replacement. Within the last 18 months, scientific advances are changing the algorithms of regenerative care for patients with symptomatic and debilitating osteoarthritis. I now have several options available for patients who would have been denied interventional orthopedic opportunity; patients who are impacted and limited by Osteoarthritis but for whom there previously was not a viable non-surgical alternative.  

 1. Alpha 2 Macroglobulin (A2M)

A2M is a very large plasma protein found in blood acting as a very strong protease inhibitor; and for patients who meet certain prerequisites, could well be highly effective in the treatment of osteoarthritis. The prerequisite is a synovial fluid analysis looking for the Fibronectin Aggrecans Complex (FAC). While it sounds complex, it is an uncomplicated testing of a sample of synovial fluid easily preformed under ultrasound guidance in the office setting. Recently, A2M became available in a synthetic recombinant format as an “off the shelf” alternative

2. Umbilical cord derived blood and cells

When our first grandchild arrived, our gift was a regenerative one; namely, the gifting of the cost of freezing her umbilical cord should there ultimately be a need for stem cells in her life. Now, there are scientific and pharmacologic interventions available from allograft umbilical cords retrieved at delivery, sterilized and frozen. It is a new but emerging resource with regenerative and pain-relieving potential for patients with osteoarthritis who otherwise have no other treatment options.

3. Amniotic fluid concentrate

While there are no living stem cells in amniotic fluid once sterilized, frozen and fast thawed, hence no regenerative possibility; the anti-inflammatory effect is real and the pain-relieving potential, although limited in duration, is being scientifically documented. Harvested by amniocentesis at the time of a cesarean section in a donor screened for communicable and infectious diseases, it is possible to repeat the intervention after a year should symptoms return. There are now “off the shelf” preparations of lyophilized Amniotic Fluid Concentrate

4. Bone Marrow Concentrate derived stem cells and growth factors

I am in the in the process of developing a protocol to be submitted for IRB oversite wherein a bone marrow analysis would be completed allowing for stem cell and growth factor analysis pretreatment not unlike a bone biopsy for a lesion prior to the definitive surgery. This would allow me a patient specific approach to those who otherwise would not be considered candidates for regenerative autograft options.

 

If you want to learn more about postponing or perhaps even avoiding surgery for a joint that alters your quality of life, call 847-390-7666.

To learn more, check out my web site at www.Sheinkopmd.com

View my webinar at www.ilcellulartherapy.com

Saving umbilical cord blood

                                               

In the beginning, there was an umbilical cord. The blood in that cord was and is an invaluable source of stem cells that is unique to your body and family. These cells may be used to treat nearly 80 serious medical conditions at last count including leukemia, other cancers, and blood disorders. Cord blood stem cells are showing significant potential to treat conditions that have no cure today as juvenile diabetes and brain injury. Saving your baby’s or your grandchild’s cord blood secures the best treatment option for a healthy future.

According to the U.S. Department of Health and Human Services, “This revolutionary technology (regenerative medicine) has the potential to develop therapies for previously untreatable conditions. Examples of diseases regenerative medicine can cure include diabetes, heart disease, renal failure, osteoporosis, and spinal cord injuries. I am now ready to announce my personal entry into the new world of regenerative medicine in conjunction with the Regenerative pain Center by having joined the Regenexx network of physicians. I will start screening patients for bone marrow concentrate pilot study as of March 25th. The actual clinical process will be introduced at the beginning of May at the Regenerative Pain Center. There is as yet no assurance that bone marrow concentrate rich with autologous mesenchymal adult stem cells administered in to an arthritic joint will reverse arthritis or even stop progression but with the anecdotal observations around the country, I believe that as an orthopedic surgeon, I might or could be able to delay or avoid a joint replacement. Our pilot study will be the first step. In order to qualify, a patient will need to meet certain criteria determined by history, physical examination, X-ray and MRI. At times, a diagnostic out patient arthroscopic examination or prior treatment may be part of the program. For those who don’t qualify for the study, the patient may still seek treatment with a self-pay alternative.

Transplant medicine uses stem cells to help treat serious diseases, such as cancers and blood disorders. Regenerative medicine is a new and rapidly advancing area of medicine focusing on developing treatments using stem cells to repair damaged tissues and organs. The estimates to date that someone in your family will use stem cells in a lifetime include:

Transplant Medicine: 1 in 217

Regenerative Medicine: 1 in 3

I am thrilled to announce my entry in to the emerging stem cell application regenerative process. To learn more or see if you qualify, call the number listed below.

Mitchell B. Sheinkop, M.D.

847-390-7666

1565 N. LaSalle St., Chicago, Illinois, 60610

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