Effectiveness and Safety of Mesenchymal Stem Cell (MSC) Implantation on Degenerative Discus Disease Patients (MSC)
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|ClinicalTrials.gov Identifier: NCT04499105|
Recruitment Status : Recruiting
First Posted : August 5, 2020
Last Update Posted : August 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Disc Disease Low Back Pain Disc Degeneration||Drug: Mesenchymal Stem Cell + NaCl 0,9% 2ml||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness and Safety of Allogenic Mesenchymal Stem Cell (MSC) Implantation on Degenerative Discus Disease Patients (Clinical Trial)|
|Actual Study Start Date :||July 24, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
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.
- 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.
- Tissue Improvement [ Time Frame: 6 months ]Tissue improvement confirmed by intervertebral disc MRI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04499105
|Contact: Ahmad Jabir Rahyussalim, PhD, SpOT(K)||+firstname.lastname@example.org|
|Contact: Tri Kurniawati, S.Siemail@example.com|
|Cipto Mangunkusumo Hospital||Recruiting|
|Jakarta Pusat, DKI Jakarta, Indonesia, 10430|
|Contact: Ahmad Jabir Rahyussalim, MD,PhD,SpOT +62811819466 firstname.lastname@example.org|
|Contact: Trie K Kurniawati, SSi +628121134311 email@example.com|
|Principal Investigator: Ahmad Jabir Rahyussalim, MD,PhD,SpOT|