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

August 4, 2020 updated by: Ahmad Jabir Rahyussalim

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Recruiting
        • Cipto Mangunkusumo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
Tissue Improvement
Time Frame: 6 months
Tissue improvement confirmed by intervertebral disc MRI
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmad Jabir Rahyussalim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2017

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

July 30, 2020

First Submitted That Met QC Criteria

July 30, 2020

First Posted (Actual)

August 5, 2020

Study Record Updates

Last Update Posted (Actual)

August 6, 2020

Last Update Submitted That Met QC Criteria

August 4, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-02-0143

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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