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"... A recent study published in Cell explored a novel stem cell therapy for advanced osteoporosis that cleverly uses a patient's own stem cells as a biological targeting tag, binding to blood vessels in the bone marrow and guiding the infused stem cells directly to damaged bone tissue.
In a first-in-human trial, 10 women over 50 with advanced osteoporosis received an infusion of the specially engineered repair cells via a single intravenous (IV) drip.
In the first two years after treatment, fractures caused by weakened bones fell by 94%, from eight fractures per year to 0.5 fractures per year, across the group.
Post-treatment bone biopsies showed that the mean bone tissue area nearly doubled in just four months. Most patients also reported less pain after receiving the infusion, with a 34% reduction at month 24. ..."
From the highlights and abstract:
"Highlights
• I.v. infusion of exofucosylated human mesenchymal stem cells (Fuc-autoBM-MSCs) is safe
• Single i.v. dose of Fuc-autoBM-MSCs lowers fragility fracture incidence in osteoporosis
• Volumetric bone mineral density increases after Fuc-autoBM-MSC i.v. infusion
• Changes in bone metabolism biomarkers are consistent with an osteoregenerative effect
Summary
Mesenchymal stem/stromal cells (MSCs) are osteoregenerative; however, their therapeutic efficacy for skeletal conditions is hampered by poor bone-homing (“osteotropism”).
In preclinical models, this deficit is correctable by MSC glycocalyx editing to enforce sialylated Lewis X (sLeX) expression, thereby programming osteotropism. We conducted a first-in-human clinical trial (ClinicalTrials.gov: NCT02566655) involving a single intravenous infusion of glycocalyx-edited autologous bone marrow-derived MSCs in ten women with advanced-stage osteoporosis.
The protocol-mandated evaluation spanned 2 years and included clinical assessments, radiographic studies, and measurements of bone turnover markers (BTMs), bone tissue area (BTA), and bone mineral density (BMD).
Thereafter, fracture and safety monitoring continued for >3 additional years for each patient.
No serious adverse events occurred. Fragility fractures were markedly and durably reduced, amidst increased osteoanabolic BTM levels, BTA, and volumetric BMD.
These findings indicate that glycocalyx editing effectuates MSC-based osteoporosis therapy and also refute notions that MSCs derived from older persons and/or diseased-tissue sites are biologically compromised."
Graphical summary
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