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

NCT05018637 | Unknown Phase 2

• 1 other identifier: 2019-11-010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

vertebral compression fracture; Back Pain

Outcome Measures

Primary Outcomes (1)

• improvement in Visual Analogue Scale

  Change in the VAS at 1, 3, 6, 9, and 12 months after the transplantation of Wharton's jelly-derived MSCs (WJ-MSCs), compared to before the transplantation. on a scale of 0 to 10, with 0 meaning no pain and 10 meaning the worst pain you can imagine.

  12 months

Secondary Outcomes (4)

• improvement in Oswestry Disability Index

  12 months

• Change in the T score (lumbar spine and femoral neck) of dual-energy x-ray absorptiometry

  12 months

• Presence of new vertebral fracture

  12 months

• Change in the bone mineral density (computed tomography) of fractured vertebrae

  12 months

Study Arms (2)

WJ-MSC group

EXPERIMENTAL

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.

Drug: WJ-MSC; Drug: Teriparatide

Teriparatide group

ACTIVE COMPARATOR

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

Drug: Teriparatide

Interventions

WJ-MSC 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.

Also known as: teriparatide

WJ-MSC group

Teriparatide 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; WJ-MSC group

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Inbo Han: lead

Study Sites (1)

CHA University, CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Osteoporotic Fractures; Back Pain

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Professor of Spine neurosurgeon, MD, PhD

Study Record Dates

• First Submitted: August 15, 2021
• First Posted: August 24, 2021
• Study Start: September 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

KR (1)