Evaluation of Clinical and Bone Density Improvement After Implantation of Allogenic Mesenchymal Stem Cell From Umbilical Cord on Osteoporosis Patients
1 other identifier
interventional
5
1 country
1
Brief Summary
This study will assess the effectiveness of the allogeneic mesenchymal cell from umbilical cord in improving the quality and quantity of spinal density of osteoporosis patients proven by the results of Bone Mass Density (BMD) examination compared to baseline and evaluate improvement of quality of pain with visual analog scale (VAS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2020
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2020
CompletedFirst Submitted
Initial submission to the registry
August 2, 2020
CompletedFirst Posted
Study publicly available on registry
August 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedAugust 7, 2020
August 1, 2020
4 months
August 2, 2020
August 6, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Bone Mass Density (BMD)
Improvement of spinal density in osteoporosis patients proven by the results of Bone Mass Density (BMD). 1. Above Standard Deviation (SD) (-1) means normal 2. Between SD (-1) and (-2.5) is classified as osteopenia. Osteopenia is a condition when bone density is lower than the average, but not as low as osteoporosis. 3. Below SD (-2.5) is categorized as osteoporosis. The numbers are expected to be higher after MSC implantation.
6 months
Visual Analog Scale (VAS)
Evaluates pain quality using Visual Analog Scale (VAS) from 0 - 10. Zero is no pain at all, one is the the least pain and ten is the most painful. The numbers are expected to be lower after MSC implantation.
6 months
Study Arms (1)
UC-Mesenchymal Stem Cell
EXPERIMENTALAllogeneic Mesenchymal Stem Cell from umbilical cord
Interventions
Eligibility Criteria
You may qualify if:
- Male patients older than 50 yrs old.
- Female patients older than 40 years old.
- Patients enrolled in Cipto Mangunkusumo Hospital with osteoporosis confirmed by BMD test.
- Patients with no history of autoimun disease (SLE, Addison's disease, Chron's disease) and other diseases related to osteoporosis.
- Patients with no history of consuming drug related osteoporosis.
- No active infection confirmed by HbsAg, HIV, CMV, Rubella and Toxoplasma examination.
- Agree to participate the study by signing informed consent form.
You may not qualify if:
- Patients with autoimun diesasde (SLE, Addison's diesase, Chron's disease and other osteoporosis related disease.
- Patients under immunosuppressive, anticoagulant or corticosteroid treatment.
- Paralysis patients after surgical treatment
- Patients under 20 years old
- Declined to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430, Indonesia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Orthopaedic and Traumatology Specialist, Principal Investigator
Study Record Dates
First Submitted
August 2, 2020
First Posted
August 6, 2020
Study Start
August 1, 2020
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
August 7, 2020
Record last verified: 2020-08