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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат human umbilical cord mesenchymal stem cell
  2\*10\^7

Первичные конечные точки

• 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 [Срок оценки: 24 weeks]

Вторичные конечные точки (6)

• Observe treatment [Срок оценки: 24weeks]
• Safety evaluation by detecting adverse events and serious adverse events [Срок оценки: 24 weeks]
• Safety evaluation by detecting Activated partial thromboplastin time (APTT) [Срок оценки: 24 weeks]
• Safety evaluation by detecting Prothrombin time (PT) [Срок оценки: 24 weeks]
• Safety evaluation by detecting Fibrinogen [Срок оценки: 24 weeks]
• Safety evaluation by detecting Thrombin time (TT) [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xuanwu Hospital Capital Medical University — Пекин

Идентификаторы

NCT: NCT04104412 · SCLnow-XW-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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