Trials / Unknown
UnknownNCT04501354
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)
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- Sponsor
- Ahmad Jabir Rahyussalim · Academic / Other
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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).
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mesenchymal Stem Cell | Mesenchymal Stem Cell + NaCl 0,9% 2ml |
Timeline
- Start date
- 2020-08-01
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
- First posted
- 2020-08-06
- Last updated
- 2020-08-07
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT04501354. Inclusion in this directory is not an endorsement.