Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Information provided by (Responsible Party):
Ahmad Jabir Rahyussalim, Indonesia University

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).

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Mesenchymal Stem Cell Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: UC-Mesenchymal Stem Cell
Allogeneic Mesenchymal Stem Cell from umbilical cord
Drug: Mesenchymal Stem Cell
Mesenchymal Stem Cell + NaCl 0,9% 2ml




Primary Outcome Measures :
  1. Bone Mass Density (BMD) [ Time Frame: 6 months ]

    Improvement of spinal density in osteoporosis patients proven by the results of Bone Mass Density (BMD).

    1. Above Standard Deviation (SD) (-1) means normal
    2. 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.
    3. Below SD (-2.5) is categorized as osteoporosis.

    The numbers are expected to be higher after MSC implantation.


  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Ahmad Jabir Rahyussalim +62811819466 rahyussalim71@ui.ac.id
Contact: Tri Kurniawati, S.Si +628121134311 trie3k@ui.ac.id

Locations
Layout table for location information
Indonesia
Cipto Mangunkusumo Hospital Recruiting
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Contact: Ahmad Jabir Rahyussalim, MD,PhD,SpOT    +62811819466    rahyussalim71@ui.ac.id   
Contact: Trie K Kurniawati, SSi    +628121134311    trie3k@ui.ac.id   
Principal Investigator: Ahmad Jabir Rahyussalim, MD,PhD,SpOT         
Sponsors and Collaborators
Ahmad Jabir Rahyussalim
Layout table for additonal information
Responsible Party: Ahmad Jabir Rahyussalim, Orthopaedic and Traumatology Specialist, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier: NCT04501354    
Other Study ID Numbers: 19-08-1018
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases