Is there a Cancer Risk with Stem Cell Therapy?

Mesenchymal stem cells can differentiate into many types of tissue including muscle, bone, cartilage and tendon.

Because mesnechymal stem cells are multipotent, there has been concern that implanted stem cells could form cancer cells.

Studies have demonstrated chromosomal abnormalities in mesenchymal stem cells that have been cultured for extended periods of time.  Other studies have demonstrated that mesnenchymal stem cells expanded  for less than 60 days poses no detectable risk of cell changes or cancer formation.

The critical question is whether mesenchymal stem cells are safe ?

Centeno et. a.l. have shown that they are safe.

Centeno, in a prospective study examined 227 patients and found no evidence of cancer formation at re-implantation site.  This finding is consistent with others who failed to find any evidence of cancer formation in mesenchymal stem cells culture expanded for limited periods.

Landmark study.  Stem cell therapy has a green light!

SAFE TO PROCEED

 

The Regenexx procedure utilizes minimally expanded autologous meenschymal stem cells to treat common orthopedic conditions.  This affords patients a non-surgical option with no extensive rehabilitation or the risks associated with anesthesia and surgery.

Regenerative Sciences Heads to South America

Regenerative Sciences, a Colorado based autologous mesenchymal stem cell therapy clinic focused on orthopedic applications, signed a licensing agreement with industry leader Stematix to bring the Regenexx procedure to various parts of South america.  From the press release:

David C. Bonner, Ph.D., Chairman and CEO of Stematix, said, “We at Stematix are excited to be working with Regenexx, the leaders in applied regenerative medicine for orthopedic. We anticipate that this cutting edge, proven treatment will provide needed care for many patients in clinics established in Latin America. We are working toward a first clinic in Argentina during 2010. The expertise and experience of Dr. Centeno and Dr. Schulz will be invaluable in establishing our clinic in Argentina, and we look forward to incorporating advances in the treatment methodology that the Regenexx clinic in Denver will lead. “

Stem Cell Therapy for Lumbar Disc Protrusions

Lumbar disc protrusions can cause lower back and leg pain which can vary from mild to severe.

Today in clinic, I had the opportunity to followup with a patient who underwent autologous stem cell therapy using the Regenexx procedure.  He has kindly allowed me to share his experience. Patient is a 37-year-old male with longstanding lower back and leg pain.  The back pain was sharp in character, constant in duration, progressive in nature and aggravated by coughing, sneezing and flexion.  He would experience episodic pain which would incapacitate him.  Physical examination was significant for lower back pain aggravated by flexion, extension and straight leg raise.

Micro-discectomy and other surgical treatments were dismissed by the patient and his family.

 4 weeks after having his own stem cells injected into the L5/S1 disc along with platelet derived growth factors, the patient had significant reduction in his back and leg pain.  MRI prior to and after stem cell therapy was significant for a reduction in the L5/S1 protrusion which is illustrated below.

 

 

 

 

 

 

 

 

 

 

 

Cryostorage: Freezing Your Stem Cells

Storage of adult autologous stem cells is appropriate when there is an interruption in therapy or the total number of cells available exceeds the number appropriate for a given application.

Freezing the cells in cryostorage is the standard.

International Cellular Medicine Society has established laboratory guidelines that address this specific and critical issue.  When freezing adult autologous stem cells it is important to prevent formation of large crystals in the cells which cause disruption of cell structure and possible cell death.  To avoid possible damage to cells, two precautions are taken:  the use of cyroprotective agents such as DMSO or glycerol and controlled rate of freezing.

Regenerative Sciences, which pioneered the Regenexx procedure has adopted the ICMS laboratory and clinical guidelines.  The quality of adult autologus mesenchymal stem cell therapy has now been elevated.

Expansion of Adult Stem Cells: Making A Drug?

Autologous, adult mesenchymal stem cells have proven to be an effective therapy for patients who have orthopedic injuries.  Specifically, autologous, adult mesenchymal stem cell therapy has regenerated cartilage in knees, hips and thumbs, repaired tendon injuries, reduced the size of protrusions in the lumbar spine and healed long bone non-union fractures.

Regenexx isolates a patients own mesenchymal stem cells in a state of the art cell culture laboratory.  Then, in an effort to provide maximal clinical results, it expands the stem cells by a factor of 1,000X.  The process takes 12-14 days and typically yields a mesenchymal stem cell count of 5-10 million cells.  The stem cells are expanded through the use of the patient’s own blood products.  No growth hormone or exogenous stimulates are utilized.  The patented process is unique in its ability to yield such a large number of autologous, mesenchymal stem cells.

In a previous blog, I discussed BMAC:  Bone Marrow Aspirate Concentrate.  The therapy involves taking a patients bone marrow, concentrating it via a centrifuge and re-injecting the concentrate into the area of damaged tissue.  The entire process is conducted in a single setting.  There is no isolation or culture expansion of the stem cells.   BMAC differs significantly from the Regenexx procedure in the type  and absolute number of stem cells injected.  BMAC  yields a high concentration of hemapoetic stem cells which will differentiate into blood products.  The important repair stem cell, mesenchymal stem cells, are in very low concentrations.

Stem Cell Therapy Accountability

Stem cell therapy has become exceedingly popular in the political, clinical, regulatory and patient advocate forums.  Many clinics both here in the United States and aboard have sprung up as a result of this international interst.  Unfortunately there is a significant amount of ambiguity in terms of understanding the basic concepts of stem cell therapy

 There are many different types of stem cells.  For simplicity,  they can be divided into embryonic and adult.  Adult stem cells can be further categorized as being allogenic, meaning that they came from another individual or autologous meaning  that they came for the same patient.   Autologous adult stem cells can be further divided based upon phenotype but the majority of the published research has been with mesenchymal stem cells.  This cell line is associated high levels of ‘repair function’.

Unfortunately patients are often unable to obtain answers to  questions whcih are critical to the success of there therapy:  what type of stem cells am I receiving, how many cells,  were the cells expanded and if so under what conditions?

In an effort to ensure patient safety a new association was been formed:  The American Stem Cell Therapy Association (ASCTA).  The ASCTA is a physician run organization with the mandate to produce a laboratory and clinical guidelines for minimal culture expansion of autologous, adult stem cells (A-ASC’s).  The group is comprised of various medical and surgical specialities whose goal is to to bring safe stem cell therapy to patients.  Please visit:  www.stemcelldoctors.org

 

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Synvisc Shoulder Injection Pain

Synvisc, also called hyaluric acid, is injectable medication used in the treatment of osteoarthritis.

Hyaluric acid is an important component of articulat cartilage.  It binds water and is responsible for the resilience of cartilage. Osteoarthritis, unfortunately erodes the articular cartilage of a joint giving rise to pain and reduction in range of motion.

Synvisc when injected into a joint is commonly referred to as viscosupplementation.  It is thought that Synvisc supplements the viscosity of the joint fluid thereby lubricating the joint whereby in theory reducing the level of pain.

It can be injected in the knee, hip and shoulder joint.

The manner in which it is injected is critical.  Most clinician inject the joint without  x-ray guidance which can result in the deposition of the Symvisc outside of the intended joint.  This can and often times does create a significant amount of pain and affords the patient no therapeutic response since the medication was not delivered into the intended joint.  Jackson demonstrated that experienced orthopedics physicians are only successfully in entering the knee joint space 71% of the time when using an anterolateral approach WITHOUT x-ray.  At the Centeno-Schultz Clinic x-ray is always utilized with viscosupplementation to ensure accurate placement of the medication and to avoid the pain associated with injection of hyaluric  acid outside of the joint space.

If Snyvisc therapy fails to provide significant pain relief, patients now have the option of utilizing their own meseenchymal stem cells to regenerate cartilage in the knee, hip and shoulder.  It is a novel, needle-in, needle-out procedure with allows patients to avoid the risk of disease transmission as well as the trauma and rehabilitation associated with surgery.

Please review knee MRI below of patient who underwent the use of her own mesenchymal stem cells to regenerate cartilage.    Pre-treatment images are on the top and demonstrate a cartilage depth ranging between 0.2- 0.3cm.  Five months post therapy, the cartiage has increased on average by 1mm. 

Regeneration of knee cartilage through stem cell therapy

Clinically the patient has had a significant reduction in her pain and an increase in her range of motion.  We just received an e-mail from her along with a picture of her daily activity:)

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