Research

Recent advancement in our understanding of the pathological disease process of degenerative musculoskeletal conditions including osteoarthritis has seen increased interest in the area of regenerative therapies, such as stem cell treatments.

Haematopoietic/Bone Marrow stem cells (HSC) have had remarkable clinical success for over 40 years, and thus serve as an important proof of concept for stem cell-based therapies. 

There exists significant animal and human research in the clinical application of stem cell therapies for osteoarthritis.

Cartilage regeneration has been shown in animal models with cartilage defects after treatment with stem cells (Dragoo et al. 2007; Cui et al. 2009). Further, well controlled trials have shown a significant improvement in lameness and range of motion in dogs following stem cell injections (Black et al, 2007, Black et al 2008).

In human research, there is growing evidence of success in the treatment of osteoarthritis. Reported case studies of bone marrow derived mesenchymal stem cell injections for symptomatic hip and knee osteoarthritis have shown improvement in pain and function (Centeno et al, 2006, Centeno et al, 2008, Pak 2011; Davachi et al. 2011; Emadedin et al, 2011).

Importantly, there is increasing evidence that confirms the ability of high dose `pure' stem cell injections - as used by MSCC - to not only improve pain and function but also influence the structure of cartilage and therefore have disease modifying properties (Jo et al. 2014, Cao et al.2014).

A recently published strictly controlled trial involving the use of peripheral blood stem cells in combination with arthroscopic surgery of knee cartilage lesions has shown significant improvement in the quality of cartilage repair (Saw et al. 2013). 

 

 

Clinical Trials

MSCC is dedicated to the ethical development and clinical application of stem cell therapies. 

In partnership with Magellan Stem Cells, MSCC is running two funded trials on knee osteoarthritis and traumatic knee cartilage injuries.

All patients being treated (whether within the funded trial or not) will be done so with formal ethics approval through an accredited Australian Health Ethics Committee and formally followed up with later publication of results. 

Download patient information sheet clinical trial 1

Download patient information sheet clinical trial 2

 

 

Risks

There are now close to 400 trials using mesenchymal stem cells registered with the National Institutes of Health. Over 30 of these are focused on musculoskeletal disease and most of these are treating osteoarthritis.

Based upon current clinical trial outcomes, mesenchymal stem cell therapy is safe. 

A recent review of trials involving a total of 1012 participants receiving stem cell therapy 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 transient elevation of temperature/fever (Lalu et al, 2012).  A further systematic review of intra-articular injections of expanded mesenchymal stem cells in over 800 patients showed evidence of safety with a period of self limiting knee discomfort being the only appreciable side effect (Peeters et al, 2012)

Patients were followed up in some studies for over 90 months. No association has been made between mesenchymal stem cell therapy and adverse events such as infection, malignancy or death.

 

Patient information on Stem Cell Therapy


 

Adipose-derived Stem Cell Therapy

Cell based therapies (including Stem Cells and Platelet-rich Plasma) offer exciting potential in treating conditions such as osteoarthritis and tendinopathy.

Adipose tissue is a rich source of adipose-derived stem cells. These cells have an ability to facilitate the growth of cartilage cells. Adipose-derived stem cells may improve symptomatic arthritis by : 

  • Reducing inflammation
  • Assisting the healing mechanism
  • Replacing/regenerating damaged cartilage or tendon

It is important to understand that not all patients are suitable for stem cell therapy. Further, not all `stem cell’ therapies are the same and it is important to understand the difference. This handout explains some of the questions that you may have regarding stem cell therapy. Further web based resources offering information regarding the development of stem cell therapies include :

  • Stem Cells Australia     http://stemcellsaustralia.edu.au/
  • National Stem Cell Foundation     http://stemcellfoundation.net.au/
  • International Society for Stem Cell Research     http://www.isscr.org/public/index.htm
  • NSW Stem Cell Network     http://www.stemcellnetwork.org.au/
  • International Cellular Society     http://www.cellmedicinesociety.org/
  • Kuala Lumpur Sports Medicine Centre     http://klsmc.com

 

 

 

Contra-Indications

Whilst current research indicates that adipose-derived stem cell injections are a safe therapy, it is contra-indicated in the following conditions : 

  • Pregnancy
  • Cancer
  • Some bleeding disorders
  • Organ failure
  • Immunosuppression
  • Uncontrolled hypertension or diabetes

What are the risks ?

There are risks associated with all medical procedures.

Harvest Procedure

  •  Infection - risk is minimised through use of a sterile harvesting technique and also prophylactic antibiotics.
  • Pain/Bruising at the site of harvest.
  • Abdominal asymmetry - the risk of asymmetry post liposuction is limited due to the small volume (20-40mls) of adipose tissue required.

Stem Cell Injections

  • Infection - to reduce chance of infection all injections are done under sterile conditions using ultrasound guidance for accuracy.
  • Pain/Discomfort - it is not uncommon for people to experience pain post injection of stem cells. You will be supplied with a script for appropriate     analgesia/pain relief. Some people may need crutches in the initial period due to discomfort.
  • Swelling - it is expected that your joint will swell post the injection of stem cells. This can be controlled using ice and a compression bandage and will improve usually within days.

There are now close to 400 trials using mesenchymal stem cells registered with the National Institutes of Health. Over 30 of these are focused on musculoskeletal disease and most of these are treating osteoarthritis.

Based upon current clinical trial outcomes, mesenchymal stem cell therapy is safe. 

A recent review of trials involving a total of 1012 participants receiving stem cell therapy 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 transient elevation of temperature/fever (Lalu et al, 2012).  A further systematic review of intra-articular injections of expanded mesenchymal stem cells in over 800 patients showed evidence of safety with a period of self limiting knee discomfort being the only appreciable side effect (Peeters et al, 2012)

Patients were followed up in some studies for over 90 months. No association has been made between mesenchymal stem cell therapy and adverse events such as infection, malignancy or death.

Research References

  • Awad HA, et al. Autologous mesenchymal stem cell-mediated repair of tendon. 1999; 5(3): 267-277
  • Diekman B, et al. Chondrogenesis of Adult Stem Cells from Adipose Tissue and Bone Marrow: Induction by Growth Factors and Cartilage Matrix. Tissue     Eng. 2010; 16(2):523-533
  • Dragoo J, et al. Healing full-thickness cartilage defects using adipose-derived stem cells. Tissue Eng. 2007; 13(7):1615-1621.
  • Jo, CH., Lee, Y., et al. (2014). “ Intra-articular injection of mesenchymal stem cells for the treatment of osteoarthritis of the knee: A proof of concept clinical trial.’ Stem Cells: Doi: 10.1002/stem.1634
  • Krampera M, et al. Mesenchymal stem cells for bone, cartilage, tendon and skeletal muscle repair. Bone. 2006; 39(4): 678-683
  • Lalu, ML., McIntyre, L., et al. (2012) “ Safety of cell therapy with mesenchymal stromal cells (safe cell): A systematic review and meta-analysis of clinical trials”, PLOS One; 7(10), open access e47559
  • Peeters, CM., Leijs, MJ., et al. (2013) “Safety of intra-articular cell-therapy with culture-expanded stem cells in humans: a systematic literature review” Osteo Cartilage; 21(10): 1465-1473.
  • Pittinger MF, et al. Multilineage potential of adult human mesenchymal stem cells. Science. 1999; 284(5411): 143-147
  • Saw KY, et al. Articular cartilage regeneration with autologous peripheral blood progenitor cells and hyaluronic acid after arthroscopic subchondral     drilling: A report of 5 cases with histology. J Arthroscopic and Rel Surg. 2011; 27(4):493-506.
  • Tuan RS, et al. Adult mesenchymal stem cells and cell-based tissue engineering. Arth Res Ther. 2003; 5(1): 32-35 
  • Uysal AC, et al. Tendon regeneration and repair with adipose derived stem cells. Curr Stem Cell Res Ther. 2010; 5(2): 161-167
  • Wakitani S, et al. Repair of articular cartilage defects in the patello-femoral joint with autologous bone marrow mesenchymal cell transplantation: three case reports involving nine defects of five knees. J Tissue Eng Regen Med. 2007; 1(1):74-79.
  • Wakitani S, et al. Safety of autologous bone marrrow-derived mesenchymal stem cell transplantation for cartilage repair in 41 patients with 45 joints followed for up to 11 years and 5 months. J Tissue Eng Regen Med. 2011; 5(2):146-150.
  • Young RG, et al. Use of mesenchymal stem cells in a collagen matrix for achilles tendon repair. J Orth Res. 1998; 16(4): 406-413