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

NCT ID: NCT05018637

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-12-31

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.

Conditions

Vertebral Compression Fracture; Osteoporotic Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

WJ-MSC group

intramedullary injection of 4 x 107 WJ-MSCs (direct injection into the recently fractured vertebra) at baseline (day 0). subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months.

Group Type: EXPERIMENTAL

WJ-MSC

Intervention Type: DRUG

Other: subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months.

Other: intramedullary injection of 4 x 107 WJ-MSCs (direct injection into the recently fractured vertebra) at baseline (day 0). subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months.

Teriparatide

Intervention Type: DRUG

subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months.

Teriparatide group

subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months.

Group Type: ACTIVE_COMPARATOR

Teriparatide

Intervention Type: DRUG

subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months.

Interventions

WJ-MSC

Other: subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months.

Other: intramedullary injection of 4 x 107 WJ-MSCs (direct injection into the recently fractured vertebra) at baseline (day 0). subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months.

Intervention Type: DRUG

Teriparatide

subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months.

Intervention Type: DRUG

Other Intervention Names

teriparatide

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)

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Inbo Han

OTHER

Sponsor Role: lead

Responsible Party

Inbo Han

Principal Investigator, Professor of Spine neurosurgeon, MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

CHA University, CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

2019-11-010

Identifier Type: -

Identifier Source: org_study_id