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

Efficacy of Wharton's Jelly-derived Mesenchymal Stem Cells in Combination With Parathyroid Hormone for Vertebral Compression Fracture

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Osteoporotic Fractures; Vertebral Compression Fracture
• Intervention / Treatment: Drug: WJ-MSC; Drug: Teriparatide

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of
      • CHA University, CHA Bundang Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: teriparatide; Drug: Teriparatide; subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months.
Active Comparator: Teriparatide group; subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months.	Drug: Teriparatide; subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvement in Oswestry Disability Index	Change in the ODI at 1, 3, 6, 9, and 12 months after the transplantation of WJ-MSCs, compared to before the transplantation. on a scale of 0 to 3, with 0 meaning no disability and 10 meaning severe disability	12 months
Change in the T score (lumbar spine and femoral neck) of dual-energy x-ray absorptiometry	Change in the T score (lumbar spine and femoral neck) of dual-energy x-ray absorptiometry at 6 and 12 months after the transplantation compared to before the transplantation	12 months
Presence of new vertebral fracture	identification of spine fracture based on x ray	12 months
Change in the bone mineral density (computed tomography) of fractured vertebrae	Change in the bone mineral density (computed tomography) at 6 and 12 months after the transplantation compared to before the transplantation	12 months

Collaborators and Investigators

• Sponsor: Inbo Han

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: August 15, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 24, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Back Pain; vertebral compression fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Compression; Osteoporotic Fractures; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Teriparatide
• Other Study ID Numbers: 2019-11-010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No