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The true scale of osteoporosis is difficult to fathom.

The progressive bone-weakening disease is estimated to affect as many as 500 million people worldwide, triggering up to 37 million fragility fractures a year.

That’s a bone breaking in someone’s body every single second.

While there’s no cure for the condition, scientists say they may have found a kind of “living medication” for the disease.

In a first-in-human phase 1 trial reported in Cell, researchers gave patients with advanced osteoporosis a modified version of their own mesenchymal stem/stromal cells (MSCs), and it showed significant bone-strengthening effects.

While the trial’s primary aim was to investigate the safety of this experimental treatment, the researchers say their findings demonstrate much more.

“The results show that this treatment approach has an excellent safety profile and is feasible,” researchers explain in the new paper, led by first author and hematologist José M. Moraleda from the University of Murcia in Spain.

“However, strikingly… the results also reveal a durable reduction in the incidence of fragility fractures accompanied by increased serum levels of bone neoformation biomarkers, coupled with radiographic and histomorphometric evidence of an osteorestorative effect within trabecular bone.”

Mesenchymal stem/stromal cells are a form of stem cell, but whereas embryonic stem cells and induced pluripotent stem cells ( iPSCs) can generate almost any cell type, MSCs are only multipotent – not pluripotent – meaning they’re more limited in the kinds of cells they can become.

However, MSCs, which can be found in bone marrow (as well as other parts of the body), are the precursors to osteoblasts, cells that create and repair bone.

In theory, this makes MSCs a promising candidate for bone-strengthening therapies to treat osteoporosis, but once MSCs are cultured outside the body and then returned intravenously, their lack of a surface molecule called Sialylated Lewis X (sLeX) hampers their ability to find the bone marrow.

“In preclinical models, this deficit is correctable by MSC glycocalyx editing to enforce sialylated Lewis X (sLeX) expression, thereby programming osteotropism,” the researchers explain.

Questions still remained, though, as to whether the same MSC modifications worked, and were safe, in human patients.

In a small trial involving 10 women with advanced osteoporosis aged between 51–72, the researchers extracted bone marrow from each participant’s hip.

Their MSCs were then isolated and cultured, before being modified with a glycocalyx tweak, designed to improve the MSCs’ ability to return to the bone marrow after being reintroduced to the bloodstream.

The edited MSCs were then delivered back to the participants via an intravenous infusion, and the participants were then monitored for approximately six years of follow-up in total.

The results showed, in terms of the primary safety measures, that the experimental treatment was well tolerated by the participants, with no treatment-related adverse events occurring.

Even more promising was that the participants exhibited a dramatic drop in bone fractures stemming from their osteoporosis.

“Though subjects in this study were clinically at ‘very high risk’ for recurrent fragility fractures, the refracture incidence dropped precipitously,” the authors note.

“Specifically, in comparing the time span of 2 years pre-infusion to 2 years post-infusion, the fracture incidence decreased from 8 events/year to 0.5 events/year – a 94 percent reduction in fragility fractures.”

In addition, bone tissue biopsies taken 120 days after the MSC infusion showed a significant increase in average bone tissue area (BTA) for seven of the 10 patients.

Bone metabolism biomarkers also showed signs of a bone-strengthening effect, and body imaging revealed improvements in the density of spongy trabecular bone.

“Collectively, the results suggest that the administered Fuc-autoBM-MSCs mediate an osteoregenerative effect predominantly within trabecular bone,” the researchers write.

“This is a critical issue given that trabecular bone is far more metabolically active than cortical bone, and, accordingly, osteoporosis predominantly disintegrates trabecular bone early in the disease, with a later erosion of cortical bone.”

Given this was primarily a safety trial and not a randomized experiment with a control group, the researchers say it will fall to future studies to investigate further what’s going on here, and to more formally measure the effects that might be happening.

Related: Rare Genetic Disorder Leaves Bones Unable to Harden – And Many Patients Don’t Even Know They Have It

The researchers also acknowledge that theirs is only a small study, with a lack of diversity in the patients involved, and they suggest that larger studies are needed, with a broader diversity of participants, and involving more study sites.

But while we have to be cautious in interpreting their results, it certainly looks like something beneficial happened to the women in this trial, and a better understanding could ultimately help improve the lives of millions of people.

As far as the researchers are concerned, it could be the beginning of a paradigm shift in how we deal with this disease.

“Precision glycocalyx editing effectuates MSC-based therapy to reverse osteoporosis, thus potentially shifting therapeutic strategies for this disease from pharmacologic approaches to regenerative medicine,” the authors write.

The findings are reported in Cell.