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

Ahmad Jabir Rahyussalim

Status and phase: Unknown; Phase 2

Conditions: Degenerative Disc Disease; Disc Degeneration; Low Back Pain

Treatments: Drug: Mesenchymal Stem Cell + NaCl 0,9% 2ml

Study type: Interventional

Funder types: Other

Identifiers

NCT04499105

17-02-0143

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Mesenchymal Stem Cell

Experimental group

Description:

Mesenchymal Stem cell + Nacl 0.9%

Treatment:

Drug: Mesenchymal Stem Cell + NaCl 0,9% 2ml