Degenerative Disc Disease, Disc Degeneration, Low Back Pain
Conditions
Keywords
DDD, MSC
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.
Interventions
DRUGMesenchymal Stem Cell + NaCl 0,9% 2ml
Patients enrolled in Cipto Mangunkusumo Hospital with degenerative disc disease with no promising result after conventional treatment.
Sponsors
Ahmad Jabir Rahyussalim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Indonesia
Contacts
Primary ContactAhmad Jabir Rahyussalim, PhD, SpOT(K)
Backup ContactTri Kurniawati, S.Si
Outcome results
None listed