NCT04499105

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2017

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 24, 2017

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 5, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 6, 2020

Status Verified

August 1, 2020

Enrollment Period

3.4 years

First QC Date

July 30, 2020

Last Update Submit

August 4, 2020

Conditions

Degenerative Disc DiseaseLow Back PainDisc Degeneration

Keywords

DDDMSC

Outcome Measures

Primary Outcomes (2)

  • 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

  • Tissue Improvement

    Tissue improvement confirmed by intervertebral disc MRI

    6 months

Study Arms (1)

Mesenchymal Stem Cell

EXPERIMENTAL

Mesenchymal Stem cell + Nacl 0.9%

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

Interventions

Mesenchymal Stem Cell + NaCl 0,9% 2mlDRUG

Patients enrolled in Cipto Mangunkusumo Hospital with degenerative disc disease with no promising result after conventional treatment.

Mesenchymal Stem Cell

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients enrolled in Cipto Mangunkusumo Hospital with degenerative disc disease with no promising result after conventional treatment.
  • No history of metabolic, autoimun and genetic disease(s).
  • No active infection (HbsAg, HIV, CMV, Rubella).
  • Agree to participate the study by signing informed consent form.

You may not qualify if:

  • Patients under 20 years old.
  • Declined to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc DegenerationLow Back Pain

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ahmad Jabir Rahyussalim, PhD, SpOT(K)

CONTACT

+62811819466rahyussalim71@ui.ac.id

Tri Kurniawati, S.Si

CONTACT

+628121134311trie3k@ui.ac.id

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. dr. Rahyussalim SpOT(K)

Study Record Dates

First Submitted

July 30, 2020

First Posted

August 5, 2020

Study Start

July 24, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

August 6, 2020

Record last verified: 2020-08

Locations

ID(1)