Evaluation of Clinical and Bone Density Improvement After Implantation of Allogenic Mesenchymal Stem Cell From Umbilical Cord on Osteoporosis Patients

Osteoporosis Clinical Trial

Official title:

Evaluation of Clinical and Bone Density Improvement After Implantation of Allogenic Mesenchymal Stem Cell From Umbilical Cord on Osteoporosis Patients (Clinical Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04501354
• Other study ID #: 19-08-1018
• Status: Recruiting
• Phase: Phase 2
• Start date: August 2020
• Est. completion date: December 2020

Study information

• Verified date: August 2020
• Source: Indonesia University
• Contact: Ahmad Jabir Rahyussalim
• Phone: +62811819466
• Email: rahyussalim71[@]ui.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Male patients older than 50 yrs old.

2. Female patients older than 40 years old.

3. Patients enrolled in Cipto Mangunkusumo Hospital with osteoporosis confirmed by BMD test.

4. Patients with no history of autoimun disease (SLE, Addison's disease, Chron's disease) and other diseases related to osteoporosis.

5. Patients with no history of consuming drug related osteoporosis.

6. No active infection confirmed by HbsAg, HIV, CMV, Rubella and Toxoplasma examination.

7. Agree to participate the study by signing informed consent form.

Exclusion Criteria:

1. Patients with autoimun diesasde (SLE, Addison's diesase, Chron's disease and other osteoporosis related disease.

2. Patients under immunosuppressive, anticoagulant or corticosteroid treatment.

3. Paralysis patients after surgical treatment

4. Patients under 20 years old

5. Declined to participate in the study

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Mesenchymal Stem Cell
Mesenchymal Stem Cell + NaCl 0,9% 2ml

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Ahmad Jabir Rahyussalim

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mass Density (BMD)	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.	6 months
Primary	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