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

Phase 2

• Conditions: Low Back Pain; Degenerative Disc Disease; Disc Degeneration
• Interventions: Drug: Mesenchymal Stem Cell + NaCl 0,9% 2ml

• Registration Number: NCT04499105
• Lead Sponsor: Ahmad Jabir Rahyussalim

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.

Study Timeline

• Study Start: 2017-07-24
• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-07-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-04
• Study First Posted: 2020-08-05
• Last Update Posted: 2020-08-06
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mesenchymal Stem Cell	Mesenchymal Stem Cell + NaCl 0,9% 2ml	Mesenchymal Stem cell + Nacl 0.9%

Primary Outcome Measures

Name	Time	Method
Improvement of Low Back Pain	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.
Tissue Improvement	6 months	Tissue improvement confirmed by intervertebral disc MRI

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia