By: ABBOTT LAW GROUP
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Stem Cell Therapy Infections
After suffering for days and months of joint pain, some people decide to try an injection of umbilical cord blood, an unproven stem cell therapy used by orthopedic clinics, chiropractors, and pain doctors. Hoping to get pain relief, patients instead may possibly get serious infections.
These products are not approved by FDA or supported by clinical research because these clinics have less robust oversight of infection control measures, potentially creating risks to patients. The FDA recommends that patients avoid receiving such stem cell therapies outside controlled clinical studies.
As of December 14, Center for Disease Control and Prevention has received 12 reports about stem cell therapy infections from three states: Texas (seven), Florida (four), and Arizona (one).
Infection types included:
- joint infections,
- epidural abscesses,
- and bloodstream infections.
All 12 patients received injections or infusions of Liveyon’s umbilical cord blood-derived stem cell products processed by Genetech, Inc.
On September 22, 2018 the Florida Department of Health announced four cases of infections with Escherichia coli, Enterococcus faecalis, and Proteus mirabilis at an orthopedic clinic.
Liveyon, LLC issued a voluntary nationwide stem cell recall of the Regen Series Product due to possible adverse reactions on October 10, 2018.
The manufacturers of umbilical cord blood must be highly controlled to prevent the distribution of contaminated products because the umbilical cord blood cannot be decontaminated due to no validated processes for sterilization.
These contaminations pose serious risks to patients of stem cell therapies administered for unapproved uses other than hematopoietic or immunologic reconstitution.
|Date administered||Setting||Condition prompting product administration*||Specimen collection date, first positive culture||Organism isolated||Infection site||Days of initial hospitalization to treat infection|
|1||Intra-articular injection, knee and shoulder||Feb 15, 2018||Orthopedic clinic||Degenerative joint disease||Feb 21, 2018||Escherichia coli, Proteus mirabilis||Knee||15|
|2||Intra-articular injection, lumbar spine||Jun 13, 2018||Pain clinic||Pain||Jun 14, 2018||Escherichia coli||Bloodstream||4|
|3||Intra-articular injection, lumbar spine||Jul 27, 2018||Ambulatory surgery center||Pain||Aug 1, 2018||Escherichia coli, Enterococcus faecalis||Bloodstream, lumbosacral epidural abscess, discitis, and vertebral osteomyelitis†||58|
|4||Intra-articular injection, knee and shoulder||Aug 3, 2018||Orthopedic clinic||Unknown||Aug 10, 2018||Escherichia coli, Enterococcus faecalis||Knee||30|
|5||Intra-articular injection, shoulders||Aug 14, 2018||Chiropractic clinic||Osteoarthritis||Aug 29, 2018||Escherichia coli||Bloodstream, shoulders||8|
|6||Intra-articular injection, shoulder||Aug 22, 2018||Orthopedic clinic||Rotator cuff tear with intrasynovial cyst||Sep 9, 2018||Escherichia coli||Shoulder||6|
|7||Intra-articular injection, lumbar spine||Aug 28, 2018||Spine treatment clinic||Lumbar back pain||Sep 1, 2018||Citrobacter koseri||Bloodstream||6|
|8||Intra-articular injection, lumbar spine||Aug 29, 2018||Pain clinic||Pain||Sep 4, 2018||Escherichia coli, Enterococcus faecalis||Bloodstream||35|
|9||Intra-articular injection, knee||Aug 30, 2018||Orthopedic clinic||Osteoarthritis||Sep 7, 2018||Escherichia coli, Enterococcus faecalis||Knee||5|
|10||Intra-articular injection, cervical spine||Sep 12, 2018||Pain clinic||Pain||Sep 15, 2018||Enterobacter cloacae, Citrobacter freundii||Bloodstream, cellulitis at injection site§||9|
|11||Intra-articular injection, cervical and lumbar spine||Sep 12, 2018||Pain clinic||Pain (history of rheumatoid arthritis)||Sep 16, 2018||Enterobacter cloacae, Citrobacter freundii||Bloodstream||12|
|12||Intra-articular injection, lumbar spine and index fingers; intravenous infusion||Sep 12, 2018||Pain clinic||Pain, rheumatoid arthritis, osteoarthritis||Sep 16, 2018||Enterobacter cloacae||Bloodstream, lumbar epidural abscess||12|