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

NCT04104412 | Recruiting Phase 1

• 1 other identifier: SCLnow-XW-01
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Discogenic Pain

Keywords

lumbar discogenic pain; mesenchymal stem cell

Outcome Measures

Primary Outcomes (1)

• 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

  Recording the VAS scores at 3, 6, 12 and 24 weeks after the operation and compare with the VAS score before the operation. Pain relief rate =(VAS before treatment - VAS after treatment)/VAS before treatment ×100%. VAS scale Use a line with 10 centimeters long as a point between 1 and 10 0 points, no pain, no pain sensation; 1-3 points, mild pain, no effect 4-6 points, moderate pain, affecting work but not life; 7-10 points, severe pain, severe pain, affect work and life. Efficacy evaluation: more than 75% is the basic remission; 50%-75% is effective; 25%-50% effective; Less than 25% is invalid. e.g. the VAS score before the operation is 8, the score in the third week after operation is 6, the pain relief rate is (8-6)/8x 100%=14.3% the VAS score before the operation is 8, the score in the sixth week after operation is 3, the pain relief rate is (8-3)/8x 100%=62.5%

  24 weeks

Secondary Outcomes (6)

• Observe treatment

  24weeks

• Safety evaluation by detecting adverse events and serious adverse events

  24 weeks

• Safety evaluation by detecting Activated partial thromboplastin time (APTT)

  24 weeks

• Safety evaluation by detecting Prothrombin time (PT)

  24 weeks

• Safety evaluation by detecting Fibrinogen

  24 weeks

Study Arms (2)

treatment group A （with mesenchymal stem cell intervention）

EXPERIMENTAL

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

Biological: human umbilical cord mesenchymal stem cell

control group B

NO INTERVENTION

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

Interventions

human umbilical cord mesenchymal stem cell BIOLOGICAL

2\*10\^7

treatment group A （with mesenchymal stem cell intervention）

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sclnow Biotechnology Co., Ltd.: lead

Study Sites (1)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Study Officials

• Yuanzhang Tang, Doctor

  Xuanwu Hospital, Beijing

  STUDY DIRECTOR

Central Study Contacts

Jiaxiang Ni, Master

CONTACT

8613910743476; nijiaxiang@yahoo.com

Lei Guo, Doctor

CONTACT

861064368977; georgeguo@sclnow.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 26, 2019
• Study Start: August 15, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: April 23, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)