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

2019-10-01 07:55:07 | BioPortfolio

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.

Study Design

Conditions

Lumbar Discogenic Pain

Intervention

human umbilical cord mesenchymal stem cell

Location

Xuanwu Hospital Capital Medical University
Beijing
Beijing
China
100053

Status

Recruiting

Source

Sclnow Biotechnology Co., Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-01T07:55:07-0400

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Medical and Biotech [MESH] Definitions

Bone-marrow-derived, non-hematopoietic cells that support HEMATOPOETIC STEM CELLS. They have also been isolated from other organs and tissues such as UMBILICAL CORD BLOOD, umbilical vein subendothelium, and WHARTON JELLY. These cells are considered to be a source of multipotent stem cells because they include subpopulations of mesenchymal stem cells.

Transplantation of STEM CELLS collected from the fetal blood remaining in the UMBILICAL CORD and the PLACENTA after delivery. Included are the HEMATOPOIETIC STEM CELLS.

Venous vessels in the umbilical cord. They carry oxygenated, nutrient-rich blood from the mother to the FETUS via the PLACENTA. In humans, there is normally one umbilical vein.

The transference of BONE MARROW from one human or animal to another for a variety of purposes including HEMATOPOIETIC STEM CELL TRANSPLANTATION or MESENCHYMAL STEM CELL TRANSPLANTATION.

Jelly-like connective tissue of the UMBILICAL CORD that contains MESENCHYMAL STROMAL CELLS.

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