Vertebral Compression FracturePhase 2NCT05018637
Efficacy of WJ-derived Mesenchymal Stem Cells in Combination With Parathyroid Hormone for Vertebral Compression Fracture
A Phase 2 study testing WJ-MSC and Teriparatide in people with Vertebral Compression Fracture and Osteoporotic Fractures, run by Inbo Han at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Vertebral Compression Fracture, Osteoporotic Fractures
- What is being tested?
- WJ-MSC and Teriparatide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2020to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
CHA University, CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do
About this study
Official title: 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.
- Being tested
- WJ-MSC, Teriparatide
- Keywords
- vertebral compression fracture, Back Pain
- Medical subject headings
- Osteoporotic Fractures, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WJ-MSCDrug
Also called teriparatide
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.
TeriparatideDrug
subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Teriparatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
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
Measured: 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
Measured: 12 months
Presence of new vertebral fracture
identification of spine fracture based on x ray
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start1 Sep 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral Compression FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inbo Han
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Inbo Han, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018637
- Sponsor's protocol ID
- 2019-11-010
- Status last verified
- Aug 2021
- First submitted
- 15 Aug 2021
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Wharton's Jelly-derived Mesenchymal Stem Cells in Combination With Parathyroid Hormone for Vertebral Compression Fracture
- ClinicalTrials.gov ID
- NCT05018637
- Acronym / sponsor ID
- 2019-11-010
- Keywords
- vertebral compression fracture, Back Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Inbo HanUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WJ-MSC group | Experimental | Drug: WJ-MSC, Drug: Teriparatideintramedullary 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 group | Active comparator | Drug: Teriparatidesubcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Postmenopausal women over 40 years of age
- Compression fracture of the spine confirmed by MRI or bone scan
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WJ-MSCAlso: teriparatideOther: 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. | Drug | WJ-MSC group |
| Teriparatidesubcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months. | Drug | Teriparatide group, WJ-MSC group |
Primary outcome
improvement in Visual Analogue Scale
Time frame: 12 months
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.
4 secondary outcomes
improvement in Oswestry Disability Index
Time frame: 12 months
Change in the T score (lumbar spine and femoral neck) of dual-energy x-ray absorptiometry
Time frame: 12 months
Presence of new vertebral fracture
Time frame: 12 months
Change in the bone mineral density (computed tomography) of fractured vertebrae
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing WJ-MSC and Teriparatide in people with Vertebral Compression Fracture and Osteoporotic Fractures, run by Inbo Han at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement in Visual Analogue Scale (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.