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

Primary Purpose

Degenerative Disc Disease, Low Back Pain, Disc Degeneration

Status
Unknown status
Phase
Phase 2
Locations
Indonesia
Study Type
Interventional
Intervention
Mesenchymal Stem Cell + NaCl 0,9% 2ml
Sponsored by
Ahmad Jabir Rahyussalim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring DDD, MSC

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cipto Mangunkusumo HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mesenchymal Stem Cell

Arm Description

Mesenchymal Stem cell + Nacl 0.9%

Outcomes

Primary Outcome Measures

Improvement of Low Back Pain
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.
Tissue Improvement
Tissue improvement confirmed by intervertebral disc MRI

Secondary Outcome Measures

Full Information

First Posted
July 30, 2020
Last Updated
August 4, 2020
Sponsor
Ahmad Jabir Rahyussalim
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1. Study Identification

Unique Protocol Identification Number
NCT04499105
Brief Title
Effectiveness and Safety of Mesenchymal Stem Cell (MSC) Implantation on Degenerative Discus Disease Patients
Acronym
MSC
Official Title
Effectiveness and Safety of Allogenic Mesenchymal Stem Cell (MSC) Implantation on Degenerative Discus Disease Patients (Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 24, 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmad Jabir Rahyussalim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease, Low Back Pain, Disc Degeneration
Keywords
DDD, MSC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal Stem Cell
Arm Type
Experimental
Arm Description
Mesenchymal Stem cell + Nacl 0.9%
Intervention Type
Drug
Intervention Name(s)
Mesenchymal Stem Cell + NaCl 0,9% 2ml
Intervention Description
Patients enrolled in Cipto Mangunkusumo Hospital with degenerative disc disease with no promising result after conventional treatment.
Primary Outcome Measure Information:
Title
Improvement of Low Back Pain
Description
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.
Time Frame
6 months
Title
Tissue Improvement
Description
Tissue improvement confirmed by intervertebral disc MRI
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients enrolled in Cipto Mangunkusumo Hospital with degenerative disc disease with no promising result after conventional treatment. No history of metabolic, autoimun and genetic disease(s). No active infection (HbsAg, HIV, CMV, Rubella). Agree to participate the study by signing informed consent form. Exclusion Criteria: Patients under 20 years old. Declined to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmad Jabir Rahyussalim, PhD, SpOT(K)
Phone
+62811819466
Email
rahyussalim71@ui.ac.id
First Name & Middle Initial & Last Name or Official Title & Degree
Tri Kurniawati, S.Si
Phone
+628121134311
Email
trie3k@ui.ac.id
Facility Information:
Facility Name
Cipto Mangunkusumo Hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad Jabir Rahyussalim, MD,PhD,SpOT
Phone
+62811819466
Email
rahyussalim71@ui.ac.id
First Name & Middle Initial & Last Name & Degree
Trie K Kurniawati, SSi
Phone
+628121134311
Email
trie3k@ui.ac.id
First Name & Middle Initial & Last Name & Degree
Ahmad Jabir Rahyussalim, MD,PhD,SpOT

12. IPD Sharing Statement

Learn more about this trial

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

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