Clinical trial NCT04104412: The Safety/Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy (19#iSCLife®-LDP) for Lumbar Discogenic Pain
Official title: The Safety/Efficacy Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy for Patients With Lumbar Discogenic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Lumbar Discogenic Pain
Keywords: lumbar discogenic pain
mesenchymal stem cell
Lead sponsor: Sclnow Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-09-26
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. age over 18
2. refractory and persistent lumbago pain for more than 6 months, with/without radiation pain in lower limbs, and poor conservative treatment effect;
3. the straight leg elevation test was 70 degrees negative;
4. 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.
5. clinical signs of nerve localization were consistent with MRI changes;
6. subject gives informed consent and signs informed consent.

Exclusion Criteria:

1. coagulation dysfunction or anticoagulant therapy;
2. intervertebral space infection, puncture site infection or systemic infection;
3. lumbago pain of non-spinal origin, such as sacroiliac joint origin pain;
4. patients who have had open surgery or other disc treatments;
5. imaging examination suggested disc prolapse, prolapse, spinal canal bone stenosis, etc.;
6. patients with vital organ system dysfunction and tumor lumbar vertebra metastasis;
7. subjects with high tumor markers (AFP/CEA/CA199/CA125);
8. the subject is pregnant or breastfeeding;
9. subjects also receive other treatments that may affect the efficacy and safety of stem cells;
10. failing to control alcohol and other substance abuse during the 6 months prior to enrollment and enrollment period;
11. 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;

Primary outcomes:
measure: 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
timeFrame: 24 weeks
Secondary outcomes:
measure: Observe treatment
timeFrame: 24weeks
measure: Safety evaluation by detecting adverse events and serious adverse events
timeFrame: 24 weeks
measure: Safety evaluation by detecting Activated partial thromboplastin time (APTT)
timeFrame: 24 weeks
measure: Safety evaluation by detecting Prothrombin time (PT)
timeFrame: 24 weeks
measure: Safety evaluation by detecting Fibrinogen
timeFrame: 24 weeks
measure: Safety evaluation by detecting Thrombin time (TT)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Yuanzhang Tang, Doctor
role: STUDY_DIRECTOR
References: