Clinical trial NCT05018637: Efficacy of WJ-derived Mesenchymal Stem Cells in Combination With Parathyroid Hormone for Vertebral Compression Fracture
Official title: Efficacy of Wharton's Jelly-derived Mesenchymal Stem Cells in Combination With Parathyroid Hormone for Vertebral Compression Fracture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Vertebral Compression Fracture
Osteoporotic Fractures
Keywords: vertebral compression fracture
Back Pain
Lead sponsor: CHA University
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 30
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoporotic vertebral compression fractures (OVCFs) are serious health problems. Transplantation of mesenchymal stem cells (MSCs) has gained considerable attention to treat osteoporosis and OVCFs because implanted healthy MSCs could be differentiated into osteoblasts and reduce the susceptibility of fractures by facilitating new bone formation.

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 is a randomized, open-label, phase 2 study.


Eligibility criteria: Inclusion Criteria:

* 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
  * Compression fracture of the spine within 6 weeks after minor trauma
* Oswestry Disability Index (ODI) due to vertebral fracture is more than 30%
* Back pain due to vertebral fracture has a Visual Analogue Scale (VAS) of 4 or higher.
* In case of writing consent for stem cell transplantation therapy

Exclusion Criteria:

* Those who used osteoporosis treatment (bisphosphonate, selective estrogen receptor modulator, or parathyroid hormone) 6 months before the start of the clinical trial due to osteoporotic vertebral fracture.
* 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.
* Those who have undergone spinal fixation surgery on the fracture site prior to the clinical trial
* Those who have a history of psychiatry or who are currently undergoing treatment, who have judged that it is difficult to proceed with the clinical trial under the judgment of the researcher
* Those who do not understand the purpose and method of this clinical trial as a study subject for drug or alcohol addiction
* Those who participated in other clinical trials within 30 days prior to participation in the clinical trial
* Those who may affect this clinical trial due to serious medical conditions (hypertension not controlled by drugs, diabetes not controlled by drugs, blood coagulation disease, cirrhosis, kidney failure, tumor) or immune deficiency
* Factors less than 10 g/dL of hemoglobin in general blood test
* If there is currently an acute systemic or local infection
* Others who have clinically significant findings deemed inappropriate for this clinical trial due to medical judgment by the person in charge of the clinical trial
* Those who are allergic to proteins required for cell production (fetal calf serum)

Primary outcomes:
measure: improvement in Visual Analogue Scale
timeFrame: 12 months
Secondary outcomes:
measure: improvement in Oswestry Disability Index
timeFrame: 12 months
measure: Change in the T score (lumbar spine and femoral neck) of dual-energy x-ray absorptiometry
timeFrame: 12 months
measure: Presence of new vertebral fracture
timeFrame: 12 months
measure: Change in the bone mineral density (computed tomography) of fractured vertebrae
timeFrame: 12 months
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA University, CHA Bundang Medical Center
state: Gyeonggi-do
Study officials:
References: