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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2020-12-31

Brief Summary

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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).

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Detailed Description

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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

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Osteoporosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UC-Mesenchymal Stem Cell

Allogeneic Mesenchymal Stem Cell from umbilical cord

Group Type EXPERIMENTAL

Mesenchymal Stem Cell

Intervention Type DRUG

Mesenchymal Stem Cell + NaCl 0,9% 2ml

Interventions

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Mesenchymal Stem Cell

Mesenchymal Stem Cell + NaCl 0,9% 2ml

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No