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

Low Back Pain Clinical Trial

— MSC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04499105
• Other study ID #: 17-02-0143
• Status: Recruiting
• Phase: Phase 2
• Start date: July 24, 2017
• Est. completion date: December 2020

Study information

• Verified date: August 2020
• Source: Indonesia University
• Contact: Ahmad Jabir Rahyussalim, PhD, SpOT(K)
• Phone: +62811819466
• Email: rahyussalim71[@]ui.ac.id
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Disc Degeneration
• Intervertebral Disc Degeneration
• Low Back Pain

Intervention

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.

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Ahmad Jabir Rahyussalim

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Primary	Tissue Improvement	Tissue improvement confirmed by intervertebral disc MRI	6 months