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

NCT ID: NCT04104412

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-15
• Study Completion Date: 2026-06-30

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.

Conditions

Lumbar Discogenic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment group A （with mesenchymal stem cell intervention）

observe the effectiveness and safety of patients by injecting human umbilical cord mesenchymal stem cells(2\*10\^7/ml normal saline) and Low temperature plasma vaporization ablation

Group Type: EXPERIMENTAL

human umbilical cord mesenchymal stem cell

Intervention Type: BIOLOGICAL

2\*10\^7

control group B

observe the effectiveness and safety of patients by injecting normal saline and Low temperature plasma vaporization ablation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

human umbilical cord mesenchymal stem cell

2\*10\^7

Intervention Type: BIOLOGICAL

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sclnow Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuanzhang Tang, Doctor

Role: STUDY_DIRECTOR

Xuanwu Hospital, Beijing

Locations

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiaxiang Ni, Master

Role: CONTACT

nijiaxiang@yahoo.com

8613910743476

Lei Guo, Doctor

Role: CONTACT

georgeguo@sclnow.com

861064368977

Facility Contacts

Jiaxiang Ni, Master

Role: primary

nijiaxiang@yahoo.com

13901743476

Yuanzhang Tang, Doctor

Role: backup

Other Identifiers

SCLnow-XW-01

Identifier Type: -

Identifier Source: org_study_id