RecruitingPhase 1NCT04104412

The Safety/Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy (19#iSCLife®-LDP) for Lumbar Discogenic Pain

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


Sponsor

Sclnow Biotechnology Co., Ltd.

Enrollment

242 participants

Start Date

Aug 15, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether injecting human umbilical cord mesenchymal stem cells into damaged spinal discs can relieve chronic low back pain (lumbar discogenic pain). Stem cell therapy aims to regenerate the disc and reduce inflammation as an alternative to surgery. You may be eligible if: - You are 18 or older - You have had persistent low back pain for more than 6 months that has not responded well to conservative treatment - Your MRI shows disc degeneration without severe prolapse or nerve compression - Your straight leg raise test is negative (70 degrees) You may NOT be eligible if: - You have a blood clotting disorder or are on anticoagulant therapy - You have an active infection in the spine or injection site - You have had prior back surgery or other disc treatments - You are pregnant or breastfeeding - You have active cancer or elevated tumor markers - You have a substance abuse problem or mental illness affecting cooperation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALhuman umbilical cord mesenchymal stem cell

2\*10\^7


Locations(1)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

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NCT04104412


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