Are Stem Cell Treatments Safe? by SkyGen

Are Stem Cell Treatments Safe?


Here’s what you need to know…

  • Adipose-derived stem cell treatments are one of the most widely used stem cell treatments in the world
  • Stem cell treatments of joints have been deemed safe by countless medical studies of thousands of patients all around the world for over 10 years
  • Stem cell treatments carry the same minimal risks of other standard injections i.e. vitamin B12 injections, cortisone, PRP – except stem cells are proven to rebuild cartilage
  • Not all stem cell clinics are created equal: It is important that stem cells are administered by experienced orthopaedic surgeons with the correct guidance equipment
  • The risks of orthopaedic joint replacement surgery are significantly greater than stem cell treatments administered by experienced orthopaedic surgeons

Types of Stem Cell Treatments

Stem cells used in joint repair can be isolated from a number of different sources including the bone marrow, blood and adipose (fat) tissue. Bone marrow-derived stem cells require surgery to remove the marrow from the thin-plated bone of the upper hip (very low numbers of cells are collected this way). Stem cells are also found in very low quantities in the blood and, once removed from the blood, are often quite limited in their activity without the growth factors and bioactive molecules found in other tissues which promote and support stem cell growth. Adipose-derived stem cells are collected together with a group of these molecules in what’s called a stomal vascular fraction (SVF). The SVF contains mesenchymal stem cells (capable of growing new cartilage and bone), growth factors, cytokines (signalling molecules), innate immune cells and other bioactive molecules that all play a role in regrowing damaged tissues.

Because their collection requires only a low-risk mini-liposuction procedure (and they demonstrate some of the most impressive results in the treatment of joint conditions), adipose-derived stem cells are one of the most widely researched stem cell types used for the treatment of joints around the world.

Long-term Medical Safety Studies

There are now over 367 trials using MSCs registered with the National Institutes of Health alone (America); over 30 of these are focused on musculoskeletal disease and most of these are treating osteoarthritis. Importantly, based upon the outcomes of previous and current clinical trials, stem cell treatment is now accepted as a low-risk medical therapy.

A recent systematic review of trials involving a total of 1,012 participants receiving intravascular autologous, allogeneic and expanded/cultured stem cells for various clinical conditions (including ischaemic stroke, Crohn’s disease, cardiomyopathy, ischaemic heart disease and graft versus host disease) did not identify any significant adverse events other than a rare occurance of temporary hyperthermia (Lalu et al, 2012).

Patients were followed up in some studies for over 90 months. This evidence of safety was further confirmed with a systematic review of intra-articular injections of expanded stem cells (Peeters et al. 2013). Importantly, no association has been made between stem cell treatments and adverse events such as infection, death or malignancy. The typical risks inherent in injectable therapies also apply to cell based therapies due to their administration route (injection). However, not even a single occurrence of these complications normally associated with routine injectables has been reported in the current literature.

Stem Cell Injection Risks

All injections carry risks. These risks are reduced when the injections are performed by trained medical professionals with years of experience. Injectables like Botox, Vitamin B and Cortisone all carry risks of infection as the needle breaks the skin’s surface.

Biological preparations like PRP and stem cells carry the same minimal risks of infection as non-biological injections, unless prepared in non-sterile conditions. SkyGen’s partnered stem cell clinic processes all stem cell preparations using a patented closed system processing (pass-box) unit, drastically reducing risk of contamination compared to open system collection units used elsewhere.

Additionally, unlike other stem cell clinics that use ‘research-only’ sonication equipment (with an identified risk of loose particle aluminium contamination), SkyGen’s partnered clinic has developed the world’s most advanced and automated, sterile clinical-grade sonication unit for the separation of cellular products. This unit further diminishes any possibility of contamination risk in the stem cell products isolated from SkyGen patients.

To date, no SkyGen patient has ever experienced any form of infection from stem cell treatment.

Safety & Treatment Quality Considerations:
Stem Cell Injections into Joints

All stem cell treatment plans and injection administrations must be provided by accredited orthopaedic or spinal surgeons with documented experience (postdoctoral fellowship preferred) in stem cell treatment administration. Make sure to check with your stem cell treatment provider that the treating physician holds a relevant orthopaedic or neurosurgical speciality qualification before proceeding with treatment of your joints or spine, respectively.

Knees, Elbows, Hands and Feet
Injections of superficial joints (i.e. knee, elbow, hand, wrists, ankle & foot) are generally guided by ultrasound imaging by the treating orthopaedic surgeon. Preliminary MRIs are often evaluated before treatment to assess appropriate treatment paths before treatment.

Regardless of how experienced the orthopaedic surgeon performing the stem cell injections, fluoroscopic guidance technology is absolutely essential for the accurate and precise guidance of injections into the hip joint capsule.  Stem cell clinics reporting that hip joint treatments are less successful than knee joint treatments attribute this difference to a lack of precision when treating via ultrasound guidance alone. At the clinic, all SkyGen patients receiving hip treatment undergo two separate injection sessions, with different protocols.

The first hip treatment session requires the highly skilled orthopaedic surgeon to guide each injection via fluoroscope to accurately and precisely inject cells into the tight intra-articular space (the hip joint capsule). These cells are purposed with the regeneration of central chondral defects, which typically cause the most pain for patients suffering from hip osteoarthritis.
The second hip treatment session requires the orthopaedic surgeon to apply prolotherapeutic procedures in the treatment of the hip’s supportive (pubofemoral/iliofemoral/ischiofemoral) ligaments and inject additional cells along the labral margins of the acetabulofemoral (hip) joint. Both treatment sessions are essential to the effective treatment of the hip joint, comprehensively addressing the pain-causing chondral defects, weakened supportive ligaments and labral margins of cartilage. For more information about our world-leading hip joint treatment plans, contact SkyGen today.

Spine (Vertebrae)
A qualified neurosurgeon is essential for the treatment of spinal (vertebral) facet joints and intervertebral discs. As with other deep joints, fluoroscopic guidance technology is absolutely essential to the accurate and precise guidance of the recommended speciality-use spinal catheter. Neurosurgeons treating without the speciality-use spinal catheter will require multiple injection sites to treat multiple areas of the spine, further increasing risk.For more detailed information on the treatment of spine, click here or contact SkyGen today.

Stem Cell Injections Intravenously (IV)

In a recent study of 12 patients receiving intravenous (IV) stem cell injections, no patients had sustained adverse events or complications when followed-up over a year after treatment. One patient (receiving the study’s highest dosage of stem cells over four separate infusions) experienced short-term fever after one of the treatments which had subsided by the next injection. The study proposed that even high dosages of stem cell infusion into the intravenous circulation was safe in both the short- and long-term following treatment.

Compared to Joint Replacement safety?

Total joint replacement surgery is not without risks of significant complications. As an example, up to 20% of patients will continue to experience knee pain and other problems following total knee replacement surgery (Bourne et al. 2010). Further, significant complications such as death, pulmonary embolism and infections requiring re-admission to hospital occur in up to 2% of patients (SooHoo et al. 06). These complication rates increase with revision procedures (replacement of the replacement). The average cost of a total knee replacement is approximately $25,000 in Australia.

*Please read: Although the information provided on this page may describe a particular patient experience and/or outcome, readers must understand that each patient presents with a unique medical history and may be recommended a different treatment/surgery by their surgeon to that described above. Individual results may vary between surgery centre/hospital, surgeon, surgery type and patient. Although SkyGen agrees to share all updates from patients at their request, SkyGen does not endorse any physical activities attempted by patients following surgery which do not follow the explicit instructions provided by their surgeon. SkyGen encourages all patients to discuss the risks of such activities with medical professionals before attempting these themselves.

Written by SkyGen Public Relations

This content is copyright and property of SkyGen Spinal & Orthopaedic. It was written to educate our patients in making informed decisions regarding their own healthcare. SkyGen is Australia's largest international collaboration between world class regenerative medicine clinics and orthopaedic hospitals.