Current treatments for osteoarthritis of the knee (OAK) are inadequate. They provide symptom relief only and do not restore articular cartilage.
This is an excerpt from a presentation at the American College of Rheumatology meeting on an ultrasound-guided procedure using autologous mesenchymal stem cells, growth factors, and fat matrix (GMSCL).
The working hypothesis was: autologous stem cells from bone marrow can be stimulated to grow cartilage if provided with...
• A proper scaffold
• Autologous growth stimulating factors
• Limited weight-bearing
Our patient profile consisted of the following...
• 22 patients
• 36-64 years of age
• 16 men; 6 women
• BMI: 21-36.1
• Kellgren-Lawrence class:
o 6 grade 2
o 10 grade 3
o 6 grade 4
In preparation, patients were given the following instructions...
• No NSAIDS (oral and topical) for one month prior and one month post
• No fish oil for one month prior and one month post
• May continue prophylactic baby aspirin
• No intraarticular injections of any kind 1 month prior or during 1 year follow up.
Our procedure can be considered analogous to "Preparing a Garden"
• Sixty cc's marrow harvested posterior iliac crest (5 cc's stem cell concentrate~ 6 million stem cells)- "seeds"
• Sixty cc's peripheral blood for creation of platelet -rich plasma (5 cc's)- "fertilizer"
• Fifteen cc's fat from abdomen or flank- "soil"
Ultrasound guided fenestration was performed in all patients.
• Purpose: stimulate acute inflammatory response
• Joint capsule sites
- joint line
- adductor tubercle
- medial patellar facet
Regional treatment of fenestrated areas and joint was followed by direct ultrasound-guided instillation of...
• Stem cells
• Platelet-rich plasma
• Subcutaneous fat
• Calcium chloride/thrombin
Post-procedure, patients were given the following instructions...
• Non-weight-bearing for two weeks
• Limited weight-bearing with brace that unloads affected compartment for four to six weeks
A summary of our results is as follows...
Data Available
• 11 Patients at 6 months
• 10 Patients at 12 months
Treatment failures
• Four patients
• Defined as patients with no clinical improvement after three months
Two other "failures"
• One person died of an unrelated illness
• One person lived too far away to come back
Five patients haven't hit the six month mark
WOMAC
? 6 Months= -19.9
SD=17.92
SEM= 5.67
? 12 Months= -7.9
SD= 9.97
SEM= 3.15
Patient VAS Pain
? 6 Months=-33.7
SD= 16.71
SEM= 5.57
? 12 Months= -25.2
SD= 25.94
SEM= 8.20
Patient Global Assessment
? 6 Months= -33.0
SD= 24.13
SEM= 8.05
? 12 Months= -33.1
SD= 19.04
SEM= 6.35
Patient 50 Foot Walk Pain
? 6 Months= -26.3
SD= 15.54
SEM= 4.91
? 12 Months= -16.7
SD= 12.05
SEM= 4.01
Physician Global Assessment
? 6 Months= -51.2
SD= 21.60
SEM= 6.83
? 12 Months= -53.0
SD= 24.15
SEM= 8.54
Placebo effect? Probably not...
Example of Celebrex vs placebo in OA trials
Mean composite WOMAC score (pain, stiffness, physical function) = -5.7 (-7.5 to -3.9)
[Bensen WG, Fiechtner JJ, McMillen JI, Zhao WW, Yu SS, Woods EM, et al. Treatment of osteoarthritis with celecoxib, a cyclooxygenase-2 inhibitor: a randomized controlled trial.Mayo Clin Proc 1999;74: 1095-1105; Zhao SZ, McMillen JI, Markenson JA, Dedhiya SD, Zhao WW, Osterhaus JT, et al.Evaluation of the functional status aspects of health-related quality of life of patients with osteoarthritis treated with celecoxib. Pharmacotherapy 1999;19: 1269-1278].
Ultrasound measurement of patello-femoral cartilage thickness at 7 standardized points
• Knee flexed to 90 degrees
• Identical sites matched for accuracy
• Five measurements each point for reproducibility
• High and low dropped and the three middle averaged
Ultrasound measurement of patello-femoral cartilage thickness at 7 standardized points
• Mean improvement from baseline to 6 months (11 pts) - 0.4 mm
• Mean improvement from baseline to 12 months (10 pts) - 0.8 mm
Conclusion
While it is an uncontrolled study, GMSCL demonstrates some promise as a treatment for OAK. Further study is recommended
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