The Safety/Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy (19#iSCLife®-LDP… (NCT04104412) | Clinical Trial Compass
RecruitingPhase 1
The Safety/Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy (19#iSCLife®-LDP) for Lumbar Discogenic Pain
China242 participantsStarted 2019-08-15
Plain-language summary
This experimental use umbilical cord mesenchymal stem cells in treatment of the early stage of lumbar discogenic pain (endogenous pain of the disc) to evaluate its safety and efficacy.
This experimental is mainly aimed at over 18years old people, regardless of gender, with refractory and persistent back pain for more than 6 months.
The efficacy and safety of mesenchymal stem cells (MSCS) were evaluated by low-temperature plasma ablation and intravertebral disc injection, which were divided into treatment group and control group.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. age over 18
✓. refractory and persistent lumbago pain for more than 6 months, with/without radiation pain in lower limbs, and poor conservative treatment effect;
✓. the straight leg elevation test was 70 degrees negative;
✓. MRI of lumbar spine showed herniated disc \< 6 mm, no obvious compression of spinal cord and nerve roots; T2-weighted mri of the lumbar spine showed decreased single/multi-segment signal (black disc sign) or High signal zone (HIZ) in the posterior part of the intervertebral disc annulus.
✓. clinical signs of nerve localization were consistent with MRI changes;
✓. subject gives informed consent and signs informed consent.
Exclusion criteria
✕. coagulation dysfunction or anticoagulant therapy;
✕. intervertebral space infection, puncture site infection or systemic infection;
✕. lumbago pain of non-spinal origin, such as sacroiliac joint origin pain;
What they're measuring
1
Validity evaluation by detection the change of the VAS pain score relief rate for Lumbar disc pain of participants in different time point and compare with the VAS pain score before treatment