- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04501354
Evaluation of Clinical and Bone Density Improvement After Implantation of Allogenic Mesenchymal Stem Cell From Umbilical Cord on Osteoporosis Patients
Evaluation of Clinical and Bone Density Improvement After Implantation of Allogenic Mesenchymal Stem Cell From Umbilical Cord on Osteoporosis Patients (Clinical Trial)
Study Overview
Detailed Description
Currently, preventive and therapeutic strategies for osteoporosis patients are based on calcium and vitamin D supplementation, the use of pharmacological agents that inhibit bone resorption such as bisphosphonates, and sometimes calcitonin. Although bisphosphonates have been found to reduce osteoporosis, clinical use for these drugs has been limited because of its potential to produce serious side effects, such as mandibular osteonecrosis and atypical femoral fractures. Therefore, new therapeutic strategies for osteoporosis are needed.
This study will assess the effectiveness of the allogeneic mesenchymal cell from umbilical cord. Patients who have received mesenchymal stem cell therapy (MSC) are expected to have positive effects such as reduced pain sensation in the back assessed by Visual Analog Scale (VAS), improvement in the range of motion (ROM), improving the quality of osteoporosis patients's bone proven by the results of Bone Mass Density (BMD) and improvement in patients' quality of life.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Ahmad Jabir Rahyussalim
- Phone Number: +62811819466
- Email: rahyussalim71@ui.ac.id
Study Locations
-
-
DKI Jakarta
-
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Recruiting
- Cipto Mangunkusumo Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: UC-Mesenchymal Stem Cell
Allogeneic Mesenchymal Stem Cell from umbilical cord
|
Mesenchymal Stem Cell + NaCl 0,9% 2ml
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Bone Mass Density (BMD)
Time Frame: 6 months
|
Improvement of spinal density in osteoporosis patients proven by the results of Bone Mass Density (BMD).
The numbers are expected to be higher after MSC implantation. |
6 months
|
Visual Analog Scale (VAS)
Time Frame: 6 months
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-08-1018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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