The Safety/Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy for Lumbar Discogenic Pain

  • STATUS
    Recruiting
  • End date
    Jul 31, 2024
  • participants needed
    242
  • sponsor
    Sclnow Biotechnology Co., Ltd.
Updated on 25 January 2021

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.

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.

Details
Condition Lumbar Discogenic Pain
Treatment human umbilical cord mesenchymal stem cell
Clinical Study IdentifierNCT04104412
SponsorSclnow Biotechnology Co., Ltd.
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Lumbar Discogenic Pain?
Do you have any of these conditions: Do you have Lumbar Discogenic Pain??
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
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