Efficacy of WJ-derived Mesenchymal Stem Cells in Combination With Parathyroid Hormone for Vertebral Compression Fracture

What Was Tested

In this phase 2 trial, researchers set out to test Teriparatide.

Osteoporotic vertebral compression fractures (OVCFs) are serious health problems.

This study compares teriparatide (PTH 1-34) injection to combined treatment with Wharton's jelly-derived MSCs (WJ-MSCs) and teriparatide (PTH 1-34) in patients with OVCFs.

It had two arms (groups): WJ-MSC group (experimental) and Teriparatide group (active comparator).

The registry classes the interventions as drug.

Who Took Part

30 planned participants were the target.

It was open to women only aged from 40 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Postmenopausal women over 40 years of age. Compression fracture of the spine confirmed by MRI or bone scan. When the T score of the lumbar spine is less than -1.0 in the bone density test using DXA (Dual energy X ray absorptiometry). Compression fracture is between 5th thoracic and 5th lumbar vertebra. When a new vertebral fracture occurs in less than 3 parts of the spine.

The full record lists 9 inclusion and 13 exclusion criteria; among the exclusions: in the case of inherited, metabolic, neoplastic, or infectious bone disease other than osteoporosis; spinal fracture with neurological symptoms; those who are taking drugs that affect bone metabolism such as steroids.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Teriparatide group and the comparison group should start out alike.

The Teriparatide group and the comparison group ran side by side rather than switching.

Being open-label, the Teriparatide study did not mask who received what.

It started in 2020-09-01 with completion listed for 2022-12-31.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 4 secondary outcomes, for example Change in the T score (lumbar spine and femoral neck) of dual-energy x-ray absorptiometry, Presence of new vertebral fracture and Change in the bone mineral density (computed tomography) of fractured vertebrae.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Teriparatide in 30 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Teriparatide compound page, all human trials.