Vail Symposium Stem Cell panel Dr. Centeno
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Transcript of Vail Symposium Stem Cell panel Dr. Centeno
What’s the Future of
Orthopedics and Will Stem Cells
Play a Role?
by Christopher J. Centeno, MD,
Centeno-Schultz Clinic, Broomfield, CO
This is what greeted me in almost every 50+ year old patient I admitted to the hospital as a medical
student in the 1980s:
In the last 30 years, almost all open heart surgery has been replaced by “percutaneous” (read
needle and catheter based) devices…
2000 2015 2030
Surgical Percutaneous Surgical Percutaneous Surgical Percutaneous
Because of cell therapies, the future of orthopedics will also be less surgery and more injections…
“This is copyrighted information, it may not be copied, reprinted, published, translated, hosted, or otherwise distributed by any means without explicit permission from the Centeno-Schultz Clinic, Regenexx or Regenerative Sciences, L.L.C.”
• 1,200 square foot clean room for same day cell processing
• Privately funded separate “research only” lab that looks like any university facility
Our Colorado practice is different…
Processing
Research
Clinic
Research…
ELISA
Real-time PCR
Flow Cytometry
Flo
ure
scent
Mic
ro
Inversion
Micro
Normoxic and Hypoxic Culture
-150 C Cryo
Advanced Centrifugation
ISO Class 7 Clean Room
ISO Class 5 BSCs
FACS
Our Process
Clinical
Research
Track Patients in
our Registry
Use Data to Guide
Treatment Decisions
Publish
Innovate In the
Lab
“This is copyrighted information, it may not be copied, reprinted, published, translated, hosted, or otherwise distributed by any means without explicit permission from the Centeno-Schultz Clinic, Regenexx or Regenerative Sciences, L.L.C.”
Published Research Randomized Controlled Trials:
Same day isolated stem cells now recruiting:
-Knee Osteoarthritis-Chicago-Knee ACL Injury-Colorado-Shoulder Rotator Cuff Tears-Colorado-Low Back Sciatica-Colorado
FDA Clinical Trail for cultured stem cells (through licensed publically traded company):
-Low Back Disc Bulges-Entering Phase 1
Patients Tracked in Clinical Registry:
Total approx. 3,500 patients treated at 20+ sites in the U.S. and Grand Cayman:
-Knee Arthitis-Knee ACL Tears-Knee meniscus tears-Hip arthritis-Hip labral tears-Shoulder arthritis-Shoulder rotator cuff tears-Elbow UCL ligaments tears-Hand/wrist arthritis-Ankle ligament tears-Foot/ankle arthritis-Low back sciatica-Low back disc bulges-Degenerative disc disease
In the world literature, our research group has published on 29% or 1,457 of the 5,029 patients who have received stem cell treatments for orthopedic conditions…
“This is copyrighted information, it may not be copied, reprinted, published, translated, hosted, or otherwise distributed by any means without explicit permission from the Centeno-Schultz Clinic, Regenexx or Regenerative Sciences, L.L.C.”
The biggest allogeneic “stem cell” treatment right now is amniotic:
• These therapies contain few if any living stem cells once they are freeze dried or frozen, shipped, and shock thawed
• Hence these are not really stem cell treatments
• Very little data on efficacy or safety when used for orthopedic indications
Two Different Types of Bone Marrow Stem Cell Processes
Bone MarrowNucleated Cell
IsolationThe stem cell fraction
of bone marrow is isolated via a
centrifuge and re-injected the same day.
Bone Marrow Mesenchymal Stem
Cell CultureThe stem cells themselves are isolated and cultured to greater numbers over a few weeks. This produces
a “pure” population of stem cells which is
different than the mix of cells produced by same
day procedures.
Simple Adipose Graft
The fat is separated from the oil and
liquid and the fat is injected (however the stem cells are
still trapped in the fat and are not
concentrated).
Stromal Vascular
Fraction (SVF)The fat is separated and then chemically digested to release
the stem cell fraction, which is
then concentrated.
Adipose Mesenchymal
Stem Cell CultureThe stem cells are
isolated and cultured to greater numbers over a few weeks. This produces
a “pure” population of stem cells which is different
than the mix of cells produced by same day
procedures.
Three Different Types of Fat Stem Cell Processes
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van
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DrugNeeds FDA Approval
DrugNeeds FDA Approval
DrugNeeds FDA Approval
TissueNo FDA Approval
TissueNo FDA Approval
Au
tolo
gou
s“This is copyrighted information, it may not be copied, reprinted, published, translated, hosted, or otherwise distributed by any means without explicit permission from the Centeno-Schultz Clinic, Regenexx or Regenerative Sciences, L.L.C.”
Does an ACL injury benefit from surgery?
-2/3rds of teens who get ACL surgery will have arthritis by the time they’re 30 (Mar 2014 AAOSM Meeting)…
-The knee after ACL surgery never regains the same position sense (Knee. 2013 Dec;20(6):532-6.)
-There is no difference in return to sport between patients who get ACL surgery and those who don’t (JBone Joint Surg Am. 2014 Aug 6;96(15):1233-1241.)
This ACL had only an injection of the patients' own stem cells using a specific protocol…
“This is copyrighted information, it may not be copied, reprinted, published, translated, hosted, or otherwise distributed by any means without explicit permission from the Centeno-Schultz Clinic, Regenexx or Regenerative Sciences, L.L.C.”
More examples…
“This is copyrighted information, it may not be copied, reprinted, published, translated, hosted, or otherwise distributed by any means without explicit permission from the Centeno-Schultz Clinic, Regenexx or Regenerative Sciences, L.L.C.”
“This is copyrighted information, it may not be copied, reprinted, published, translated, hosted, or otherwise distributed by any means without explicit permission from the Centeno-Schultz Clinic, Regenexx or Regenerative Sciences, L.L.C.”
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For demographics, N for age calculation was 998, for BMI 925. Numbers of patients followed up for outcomes were the following: 461 at 1 month, 444 at 3 months, 371 at 6 month, 232 at 12 months,154 at 18 at months,100 at 24 at months and 47 at 36 months, 10 at 48 months. The expected follow-up Ns were: 928 at 1 month, 838 at 3 months, 699 at 6 months, 447 at 12 months, 307 at 18 months, 211 at 24 months, 97 at 36 months, 20 at 48 months. There we 67 study exits during the 4 year period, with 19 due to TKA. It also should be noted that 7 of the 35 patients due to report at 4 years had reported needing a TKA. Study exits were not counted above in the expected follow-up Ns at any given time point as they had refused additional follow-up.
Regenexx-SD
N 999 procedures
Male 604 (60.5%)
Female 395 (39.5%)
Age 55.5 (13-92)
Height 68.1”(49-83)
Weight 177 (100-315) lbs.
BMI 26.8 (16-55.8)
Patient DemographicsWhat’s important here? The patient
results detailed on this infographic are mostly men who are middle aged and only slightly overweight (BMI>25).
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100 Percentage of Patients Reporting >50% Improvement
Mean Improvement of All Patients
18 U.S. sites
“This is copyrighted information, it may not be copied, reprinted, published, translated, hosted, or otherwise distributed by any means without explicit permission from the Centeno-Schultz Clinic, Regenexx or Regenerative Sciences, L.L.C.”
Details For Analysis: Patients with available pain scores were 710, 396, 402, 307, 155, 102, 82, and 46 at the sequential time points (starting at pre-treatment and ending with 36 months post-treatment). Patients with available LEFS score were 662, 388, 394, 290, 149, 98, 78 and 43 at the same sequential time points. It should be noted that this dataset contains both Regenexx-SD and Regenexx-SD Plus cases.
Pain and Function DataFall 2014 710 Treated Patients
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Re
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LE
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LEFS means reported by patients
18 U.S. sites
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“This is copyrighted information, it may not be copied, reprinted, published, translated, hosted, or otherwise distributed by any means without explicit permission from the Centeno-Schultz Clinic, Regenexx or Regenerative Sciences, L.L.C.”
Can we improve outcomes by dramatically changing how stem cells are processed?
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Function 0-10 N.P.S. Self-report
Gen1 n=109Gen 2 n=92
Difference=0.03
Gen1 n=121Gen 2 n=99
Difference=0.0001
Gen1 n=278Gen 2 n=114
Difference=0.17
“This is copyrighted information, it may not be copied, reprinted, published, translated, hosted, or otherwise distributed by any means without explicit permission from the Centeno-Schultz Clinic, Regenexx or Regenerative Sciences, L.L.C.”
What does the next 15-30 years look like?
• Orthopedics will become more injection based
• New cell based therapies will change the mantra from “cut” to “heal”
• Fewer joint replacements
• Advanced needle and catheter based devices will be developed in orthopedics, just like what happened in cardiology
Conclusions:• Stem cells and other cell based therapies will turn the
orthopedics world upside down-benefitting patients
•Already, our group is beginning to challenge the concept that ACL surgery will be needed for most patients
•We can already manage arthritis in many joints and help many patients avoid more invasive joint replacement