Most physicians have an understanding of stem cells. This is meant as a brief review/update of pertinent terms and concepts. We will also cover how physicians can provide stem cell therapy for their patients and at the same time gain a revenue stream not dependent on insurance/third party payments. See the section on How I can get involved.
A: Fundamentally, stem cells are cells that share two important characteristics: 1) the ability to replicate or multiply and, 2) the ability to differentiate in other cells and tissues. These cells can be identified by a surface antigen marker designated CD34+. Stem cells from and embryonic source have an universal ability to multiply and differentiate into any cell type. This is not surprising since every cell in our bodies come from a single fertilized egg. Use of embryonic cells has many moral and ethical implications and is severely restricted in the USA. Most stem cells used clinically in the USA are adult stem cells. The term adult stem cells refers to cells that have differentiated beyond the embryonic stage. These cells can be found throughout the body. Bone marrow and fat/adipose tissue are the most widely used in the USA. Cells from marrow or adipose are typically hematopoietic stem cells (HSC) or mesenchymal stem cells (MSC). Umbilical cord derived stem cells (USC) are also HSC or MSC. So, umbilical cord stem cells are classified as adult stem cells similar to marrow or adipose.
A: The primary reason for the clinical use of stem cells is their role in healing. Since all replacement cells are generated from stem cells, they play a fundamental role in healing after injury and disease. The clinical use of stem cells involves making stem cells “bio-available” in tissues or disease states they are naturally not available or are available in limited numbers. MSC have shown the ability to transdifferentiate into1:
4. Nerve tissue
5. Blood vessels
6. Connective tissue
8. Pluri-potent cells by special techniques
MSC therefore have the potential to form replacement cells in each of those tissues. By becoming pluri-potent cells they have the potential to form replacement cells in any tissue2. In addition to their ability to replicate any cell, MSC have both micro environment and immuno-modulating effects. These effects play significant roles in their healings effects. In some disease states, such as connective tissue diseases and ischemic vascular disease the micro environment effects and immuno-modulating effects may be the primary mechanism of action.
A: Stem cell transplants from bone marrow aspirates have been in use in the United States for over three decades. This make Americans more comfortable with bone marrow. However, the number of HSC that can be obtained in a single session from bone marrow is limited. Rarely can more that 60,000 stem cells be obtained in a single session. Adipose tissue typically gets 50-100 million cells are present when fat is harvested. These are a combination of both MSC and HSC3. Adipose is both easier and more comfortable to harvest. These are the primary reasons that adipose is becoming the preferred source for MSC.
Umbilical cord cells are excellent for both their donor and for HLA matched recipients for some disorders4. However, many of the procedures being done utilizing USC are not doing HLA type matching. Instead, they rely on the lower antigenicity claimed for USC and the commonly used process of pooling cells. Pooling is the process of combining the cells of multiple individuals into a single donor allotment. In theory, this increases the chance that some of the cells will not be rejected by the recipient. Unfortunately, it exposes the recipient to the cells of multiple individuals. There have also been concerns about the sterility and viability of many commercially available USC products.
A: MSC are easily obtained via syringe liposuction under local anesthesia. An area approximately 15-20 cm is numbed with a dilute, buffered lidocaine solution. Typically this is somewhere around the patient’s waist, but can be anywhere with adequate FAT. A syringe with special discs is used and fat suction is applied by pulling back on a locking plunger. This fat is centrifuged and separated from the fluid elements. It is then incubated in collagenase and again centrifuged. After incubation, the denser MSC migrate to the bottom of the syringe. This portion is then washed to remove the collagenase and the remaining product is ready for use.
A: MSC are then deployed back to the patient. The exact means of deployment depends on the condition being treated. For instance arthritic joints typically receive intra-articular injections. Peripheral neuropathy patients receive soft tissue injections along the path of the affected nerves. Most patients receive MSC as well.
A: Innovations Medical is a member of the Cell Surgical Network (CSN). CSN has over 100 members nation wide and 150 internationally. CSN is affiliated with The International Cell Surgical Society (ICSS). ICSS approves all of our MSC processing and deployment protocols. They also review the data and provide oversight and recommendations to CSN. All of the physicians input patient data into a common database that can then be used to determine results. Following are data from some of the more common disorders.
A: The harvesting and processing of the adipose tissue into MSC is very detailed and precise. Most physicians offices are not set up to do the this part of stem cell work. However, the deployment part of the process involves common minor medical procedures that are already done in many offices. Joint injections, soft tissue injections and hand held nebulizers are used in many offices every day. Intravenous infusions are also performed in many offices. Physicians charge for services rendered. Therefore, any physician qualified to deploy the cells via soft tissue injection, joint injection, IV or other special IRB approved mechanisms can do so and charge for that service. The physician’s office can set the charges between themselves and the patient. No third party is involved. This is an opportunity to deliver great services for your patients and gain a revenue stream independent from third party payors. You are probably covered for IV and injections by your malpractice provider. If you sign a network affiliate contract, you will also have malpractice coverage through the Cell Surgical Network. Finally, the Texas Medical Board prohibits judgements against physicians performing stem cell procedures under IRB oversight solely because they are using stem cells.
A: Please feel free to contact Dr. Bill Johnson via email at:
or by phone at: 214-420-7970
We will schedule a time to meet or converse by phone to answer questions. We are also happy to arrange for you to observe a case.