Evaluation of Clinical and Bone Density Improvement After... | NCT04501354

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2020Estimated

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Aug 2, 2020

First Submission Date that Met QC Criteria

Aug 2, 2020

First Posted Date

Aug 6, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2020

Last Update Posted Date

Aug 7, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmad Jabir Rahyussalim, Orthopaedic and Traumatology Specialist, Principal Investigator, Indonesia UniversitySponsor-Investigator

Lead Sponsor

Ahmad Jabir RahyussalimOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UC-Mesenchymal Stem Cell	Experimental	Allogeneic Mesenchymal Stem Cell from umbilical cord	Drug: Mesenchymal Stem Cell

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mesenchymal Stem Cell	Drug	Mesenchymal Stem Cell + NaCl 0,9% 2ml	UC-Mesenchymal Stem Cell

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male patients older than 50 yrs old.
Female patients older than 40 years old.
Patients enrolled in Cipto Mangunkusumo Hospital with osteoporosis confirmed by BMD test.
Patients with no history of autoimun disease (SLE, Addison's disease, Chron's disease) and other diseases related to osteoporosis.
Patients with no history of consuming drug related osteoporosis.
No active infection confirmed by HbsAg, HIV, CMV, Rubella and Toxoplasma examination.
Agree to participate the study by signing informed consent form.

Exclusion Criteria:

Patients with autoimun diesasde (SLE, Addison's diesase, Chron's disease and other osteoporosis related disease.
Patients under immunosuppressive, anticoagulant or corticosteroid treatment.
Paralysis patients after surgical treatment
Patients under 20 years old
Declined to participate in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmad Jabir Rahyussalim	Contact	+62811819466		rahyussalim71@ui.ac.id
Tri Kurniawati, S.Si	Contact	+628121134311		trie3k@ui.ac.id

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cipto Mangunkusumo Hospital	Recruiting	Jakarta Pusat	DKI Jakarta	10430	Indonesia

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D001851	Bone Diseases, Metabolic
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases