The Safety/Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy (19#iSCLife®-LDP) for Lumbar Discogenic Pain
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: human umbilical cord mesenchymal stem cell.
- Who it may be relevant to
- Registry conditions: Lumbar Discogenic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Safety/Efficacy Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy for Patients With Lumbar Discogenic Pain
Overview
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.
Detailed description
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 straight leg elevation test was 70 degrees negative. Magnetic Resonance Imaging (MRI) of the 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/multisegment signal in the intervertebral disc (black disc sign) or High intensity zone (HIZ) in the posterior part of the intervertebral disc annulus. The clinical signs of nerve localization were consistent with MRI changes.
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.
The safety evaluation including:physical examination, vital signs, routine hematuria and faeces, liver and kidney function, blood lipids, electrolytes, coagulation, rapid virus detection, tumor markers, electrocardiogram and adverse reaction records at the 3, 6, 12 and 24 weeks before and after treatment.
The prime efficacy evaluation is VAS( visual analogue scale) at the 3, 6, 12 and 24 weeks before and after treatment.
Interventions
- Biological human umbilical cord mesenchymal stem cell
2\*10\^7
Primary outcome measures
- 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 [Time frame: 24 weeks]
Secondary outcome measures (6)
- Observe treatment [Time frame: 24weeks]
- Safety evaluation by detecting adverse events and serious adverse events [Time frame: 24 weeks]
- Safety evaluation by detecting Activated partial thromboplastin time (APTT) [Time frame: 24 weeks]
- Safety evaluation by detecting Prothrombin time (PT) [Time frame: 24 weeks]
- Safety evaluation by detecting Fibrinogen [Time frame: 24 weeks]
- Safety evaluation by detecting Thrombin time (TT) [Time frame: 24 weeks]
Eligibility criteria
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;
- patients who have had open surgery or other disc treatments;
- imaging examination suggested disc prolapse, prolapse, spinal canal bone stenosis, etc.;
- patients with vital organ system dysfunction and tumor lumbar vertebra metastasis;
- subjects with high tumor markers (AFP/CEA/CA199/CA125);
- the subject is pregnant or breastfeeding;
- subjects also receive other treatments that may affect the efficacy and safety of stem cells;
- failing to control alcohol and other substance abuse during the 6 months prior to enrollment and enrollment period;
- the subjects suffer from mental illness, or lack of understanding, communication and cooperation, and cannot be guaranteed to follow the study protocol;
Subjects who are not willing to sign informed consent and are participating in other clinical trials or have participated in other clinical trials within 3 months;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Xuanwu Hospital Capital Medical University — Beijing
Identifiers
NCT: NCT04104412 · SCLnow-XW-01