Evaluation of Clinical and Bone Density Improvement After Implantation of Allogenic Mesenchymal Stem Cell From Umbilical Cord on Osteoporosis Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04501354|
Recruitment Status : Recruiting
First Posted : August 6, 2020
Last Update Posted : August 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis||Drug: Mesenchymal Stem Cell||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Clinical and Bone Density Improvement After Implantation of Allogenic Mesenchymal Stem Cell From Umbilical Cord on Osteoporosis Patients (Clinical Trial)|
|Estimated Study Start Date :||August 2020|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: UC-Mesenchymal Stem Cell
Allogeneic Mesenchymal Stem Cell from umbilical cord
Drug: Mesenchymal Stem Cell
Mesenchymal Stem Cell + NaCl 0,9% 2ml
- Bone Mass Density (BMD) [ Time Frame: 6 months ]
Improvement of spinal density in osteoporosis patients proven by the results of Bone Mass Density (BMD).
- Above Standard Deviation (SD) (-1) means normal
- 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.
- Below SD (-2.5) is categorized as osteoporosis.
The numbers are expected to be higher after MSC implantation.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04501354
|Contact: Ahmad Jabir Rahyussalimfirstname.lastname@example.org|
|Contact: Tri Kurniawati, S.Siemail@example.com|
|Cipto Mangunkusumo Hospital||Recruiting|
|Jakarta Pusat, DKI Jakarta, Indonesia, 10430|
|Contact: Ahmad Jabir Rahyussalim, MD,PhD,SpOT +62811819466 firstname.lastname@example.org|
|Contact: Trie K Kurniawati, SSi +628121134311 email@example.com|
|Principal Investigator: Ahmad Jabir Rahyussalim, MD,PhD,SpOT|