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Effectiveness and Safety of Mesenchymal Stem Cell (MSC) Implantation on Degenerative Discus Disease Patients (MSC)

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ClinicalTrials.gov Identifier: NCT04499105
Recruitment Status : Recruiting
First Posted : August 5, 2020
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmad Jabir Rahyussalim, Indonesia University

Brief Summary:
This study evaluates the effectivity and safety of MSC implantation on Degenerative Disc Disease Patients by assessing visual analog scale, ROM improvement and MRI examination.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Low Back Pain Disc Degeneration Drug: Mesenchymal Stem Cell + NaCl 0,9% 2ml Phase 2

Detailed Description:

The team plan to conduct research to look at the effectiveness and safety of mesenchymal stem cell implantation therapy in intervertebral disc degeneration patients.

The use of allogenic mesenchymal stem cells from the umbilical cord was chosen because patients with degeneration of the intervertebral disc are elderly (over 50 years old) so that autologous mesenchymal stem cell administration is not possible in terms of taking the source of cells (bone marrow) nor the quality of mesenchymal stem cells obtained.

This study will assess the improvement of clinical symptoms (VAS to assess pain scale, ASIA and Frankel scale, as well as assessment of the widening of the lumbar region using the Schober Test), changes in the structure of the intervertebral discs (through MRI examination and grading the degree of intervertebral disc degeneration), conduction function spinal cord nerve (somatosensory evoked potential / SSEP), myelography / EMG, and assessment of the quality of life status of patients using the Oswestry Disability Index.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Allogenic Mesenchymal Stem Cell (MSC) Implantation on Degenerative Discus Disease Patients (Clinical Trial)
Actual Study Start Date : July 24, 2017
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: Mesenchymal Stem Cell
Mesenchymal Stem cell + Nacl 0.9%
Drug: Mesenchymal Stem Cell + NaCl 0,9% 2ml
Patients enrolled in Cipto Mangunkusumo Hospital with degenerative disc disease with no promising result after conventional treatment.




Primary Outcome Measures :
  1. Improvement of Low Back Pain [ 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.

  2. Tissue Improvement [ Time Frame: 6 months ]
    Tissue improvement confirmed by intervertebral disc MRI



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients enrolled in Cipto Mangunkusumo Hospital with degenerative disc disease with no promising result after conventional treatment.
  2. No history of metabolic, autoimun and genetic disease(s).
  3. No active infection (HbsAg, HIV, CMV, Rubella).
  4. Agree to participate the study by signing informed consent form.

Exclusion Criteria:

  1. Patients under 20 years old.
  2. 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): NCT04499105


Contacts
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Contact: Ahmad Jabir Rahyussalim, PhD, SpOT(K) +62811819466 rahyussalim71@ui.ac.id
Contact: Tri Kurniawati, S.Si +628121134311 trie3k@ui.ac.id

Locations
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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
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Responsible Party: Ahmad Jabir Rahyussalim, Dr. dr. Rahyussalim SpOT(K), Indonesia University
ClinicalTrials.gov Identifier: NCT04499105    
Other Study ID Numbers: 17-02-0143
First Posted: August 5, 2020    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmad Jabir Rahyussalim, Indonesia University:
DDD
MSC
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Low Back Pain
Back Pain
Pain
Neurologic Manifestations
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases