Overview

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

Status:
Recruiting
Trial end date:
2020-12-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ahmad Jabir Rahyussalim
Criteria
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