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

Primary Purpose

Vertebral Compression Fracture, Osteoporotic Fractures

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
WJ-MSC
Teriparatide
Sponsored by
Inbo Han
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertebral Compression Fracture focused on measuring vertebral compression fracture, Back Pain

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • CHA University, CHA Bundang Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

WJ-MSC group

Teriparatide group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
Presence of new vertebral fracture
identification of spine fracture based on x ray
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

Full Information

First Posted
August 15, 2021
Last Updated
August 23, 2021
Sponsor
Inbo Han
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1. Study Identification

Unique Protocol Identification Number
NCT05018637
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Inbo Han

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertebral Compression Fracture, Osteoporotic Fractures
Keywords
vertebral compression fracture, Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WJ-MSC group
Arm Type
Experimental
Arm Description
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.
Arm Title
Teriparatide group
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
WJ-MSC
Other Intervention Name(s)
teriparatide
Intervention Description
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
Intervention Name(s)
Teriparatide
Intervention Description
subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months.
Primary Outcome Measure Information:
Title
improvement in Visual Analogue Scale
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
improvement in Oswestry Disability Index
Description
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
Time Frame
12 months
Title
Change in the T score (lumbar spine and femoral neck) of dual-energy x-ray absorptiometry
Description
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
Time Frame
12 months
Title
Presence of new vertebral fracture
Description
identification of spine fracture based on x ray
Time Frame
12 months
Title
Change in the bone mineral density (computed tomography) of fractured vertebrae
Description
Change in the bone mineral density (computed tomography) at 6 and 12 months after the transplantation compared to before the transplantation
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
CHA University, CHA Bundang Medical Center
City
Seongnam-si
State/Province
Gyeonggi-do
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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