Lumbar Disc DegenerationPhase 1NCT06589271

SCLife®-LDD hUC-MSCs Injection Therapy for Patients With Lumbar Intervertebral Disc Degeneration

A Phase 1 study testing human umbilical cord mesenchymal stem cell suspension and total endoscopic extraction of lumbar nucleus pulposus in people with Lumbar Disc Degeneration, run by Sclnow Biotechnology Co., Ltd. at 1 site in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Lumbar Disc Degeneration
What is being tested?: human umbilical cord mesenchymal stem cell suspension and total endoscopic extraction of lumbar nucleus pulposus
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteChina
Study dates: 31 Dec 2026to 31 Dec 2027
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Age: 18-60 years old;
The symptoms are lumbago combined with radiating pain of one lower limb;
Failed conservative treatment for 3 months, including physical therapy, manual therapy and non-morphine drug therapy;
CT/MRI clearly highlighted the nucleus pulposus pressing the nerve root and the location was consistent;
Symptoms and imaging showed unilateral lumbar disc herniation;
Imaging showed single-level lumbar disc herniation;

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MRI (T2WI) of Pfirrmann disc degeneration: Grade I-IV;
Lumbar disc herniation segments: L3-4, L4-5, L5-S1;
Unilateral full endoscopic extraction of nucleus pulposus;
Sign the informed consent;
No previous history of spinal surgery.

Who cannot join

Previous history of tumor and spinal infection;
Patients with severe coagulation disorders, a history of drug abuse or taking oral anticoagulants;
Coma or incapacitation;
MRI contraindications (history of cardiovascular and cerebrovascular stent implantation, pacemaker, biostimulator, etc.);
Pregnant women;
Pregnancy or breastfeeding;

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Have participated in other clinical trials related to this project within the past 30 days;
Those who have received stem cell therapy;
Poor compliance, or can not correctly understand the cooperation so that it can not complete the interview;
Received intervertebral disc interventional therapy within the past 3 months, such as radiofrequency, laser ablation, protease injection, Ozone injection;
Highly allergic or have a history of severe allergies;
Patients with severe autoimmune disease or who are receiving immunosuppressive therapy;
Serious uncontrolled infection or high fever;
Patients with shock, failure of vital organs and unstable vital signs;
X-ray showed that the degree of stenosis of the diseased segment was more than 30% compared with the adjacent normal segment;
Imaging showed lumbar disc herniation complicated with calcification;
Imaging showed lumbar disc herniation with Modic Change;
Imaging showed lumbar disc herniation complicated with severe spinal stenosis;
Imaging showed lumbar disc herniation complicated with lumbar spondylolisthesis;
Imaging showed lumbar disc herniation combined with spinal deformity;
Mental disorders, cognitive disorders, or other physical diseases affecting the research results;
Doctors believe that there are other reasons for not being included in the treatment.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai General Hospital
Shanghai, 200080

Other trials in China

About this study

Official title: A Clinical Research on SCLife®-LDD hUC-MSCs Injection Therapy for Patients With Lumbar Intervertebral Disc Degeneration

In recent years, total endoscopic extraction of nucleus pulposus has been widely used in the treatment of lumbar disc herniation due to its advantages of less trauma, faster recovery and less cost. However, the residual nucleus pulposus may protrude again after extraction, and the stability of the operative segment decreases and the degeneration of the diseased segment accelerates. Therefore, while decompression of nerve root is completed under total endoscopic nucleus pulposus extraction, tissue engineering of nucleus pulposus is urgently needed to replace the lost part, repair the remaining nucleus pulposus, and enable the disc to be re-sealed and pressurized. Nucleus pulposus tissue engineering is mainly based on cell therapy, and the corresponding biological scaffolds are selected to transplant cells into the diseased area for treatment. However, the current nuclear tissue engineering has some shortcomings, such as limited seed cell source, difficult survival of seed cells, inflammatory rejection in the transplantation area, poor mechanical properties of biological scaffolds, poor degradation performance, and inability to produce biospecific reactions between materials and cells, which seriously restrict the clinical application of nuclear tissue engineering. Human umbilical cord mesenchymal stem cells (hUC-MSCs) are ideal seed cells for the treatment of lumbar disc herniation due to their wide availability, strong proliferation ability and good immune regulation. Therefore, in this project, hUC-MSCs are used for cell transplantation into the vertebral disc of diseased vertebrae. As the treatment method of this project is extremely minimally invasive, it is conducive to the widespread promotion of the technology.

Read the detailed description

In order to initially observe the safety and effectiveness of human umbilical cord mesenchymal stem cells (hUC-MSCs) transplantation in the treatment of lumbar disc degeneration, this project planned to include a single group of 20 patients with lumbar disc herniation, and adopt an open study design of non-random, self-controlled, single-dose group, and locally inject 2mL hUcMSCs into the lumbar disc of enrolled patients.

The patients were followed up 3, 6 and 12 months after injection to evaluate the safety of hUC-MSCs. Meanwhile, the improvement of patients' low back pain and quality of life were evaluated. Lumbar MRI is used to evaluate the improvement of patients' lumbar disc signal, proving that hUC-MSCs transplantation can delay lumbar disc degeneration and treat lumbar degenerative diseases.

Conditions: Lumbar Disc Degeneration
Being tested: human umbilical cord mesenchymal stem cell suspension, total endoscopic extraction of lumbar nucleus pulposus
Medical subject headings: Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

human umbilical cord mesenchymal stem cell suspensionBiological
2 * 10^7 cells (2ml)
total endoscopic extraction of lumbar nucleus pulposusProcedure or surgery
hUC-MSCs are injected into the opposite side of the minimally invasive surgical site immediately after surgery, and the puncture needle remains for 1 minute after injection and then pull out to prevent cell suspension leakage

Study groups in NCT06589271
Study group	Role	What they receive
hUC-MSCs transplantation group	Experimental	Human Umbilical Cord Mesenchymal Stem Cells Receives: Biological: human umbilical cord mesenchymal stem cell suspension
control group	Active comparator	suspension transplantation Receives: Procedure: total endoscopic extraction of lumbar nucleus pulposus

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of lumbar disc MRI (T2WI) signal values
Lumbar MRI images are taken on day 0-1 (measured before stem cell transplantation), 3 months, 6 months and 12 months to record the signal value of the intervertebral disc (4 times in total) from level IV-V to level III and below.
Measured: 12 months

Secondary outcomes (3)

Lower back pain and lower extremity radiating pain relief
VAS scores of low back pain and lower extremity radiative pain are recorded on day 0-1 (measured before stem cell transplantation), 3 months, 6 months, and 12 months (4 times in total) from score 4-10 to score 3 and below.
Measured: 12 months
X-ray Disc Height Index (DHI)
On day 0-1 (measured before stem cell transplantation), 3 months, 6 months, and 12 months, the patients take anterior and lateral lumbar X-rays and record the DHI value (4 times in total) to reach the outcome of DHI≤0.188.
Measured: 12 months
MRI highlights changes in the size of the nucleus pulposus
On day 0-1 (measured before stem cell transplantation), 3 months, 6 months and 12 months, lumbar MRI is taken to measure the size of the protruded nucleus pulposus and record (4 times in total) to reach the outcome of size between 0.7cm×0.5cm×0.5cm and 2.4cm×2.0cm×1.5cm.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Dec 202631 Dec 2027

First posted19 Sep 2024
Study start31 Dec 2026 (estimated)
Primary completion30 Jun 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Why it stopped: Lack of financial support

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lumbar Disc DegenerationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: non-randomized, self-controlled, single-dose
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06589271
Sponsor's protocol ID: SCLnow-SH-01
Status last verified: Dec 2025
First submitted: 5 Sep 2024
Last updated: 27 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Lumbar Disc Degeneration trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Research on SCLife®-LDD hUC-MSCs Injection Therapy for Patients With Lumbar Intervertebral Disc Degeneration
ClinicalTrials.gov ID: NCT06589271
Acronym / sponsor ID: SCLnow-SH-01
Conditions: Lumbar Disc Degeneration
Phase: Phase 1
Study type: Interventional
Recruitment status: SuspendedReason stopped: Lack of financial support
Enrolment: 20 participants (estimated)
Lead sponsor: Sclnow Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
Study start: 31 Dec 2026 (estimated)
Primary completion: 30 Jun 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 19 Sep 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: non-randomized, self-controlled, single-dose

Arm	Type	Receives
hUC-MSCs transplantation group	Experimental	Biological: human umbilical cord mesenchymal stem cell suspensionHuman Umbilical Cord Mesenchymal Stem Cells
control group	Active comparator	Procedure: total endoscopic extraction of lumbar nucleus pulposussuspension transplantation

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Age: 18-60 years old;
The symptoms are lumbago combined with radiating pain of one lower limb;
Failed conservative treatment for 3 months, including physical therapy, manual therapy and non-morphine drug therapy;
CT/MRI clearly highlighted the nucleus pulposus pressing the nerve root and the location was consistent;
Symptoms and imaging showed unilateral lumbar disc herniation;

Key exclusion criteria (22 listed)

Previous history of tumor and spinal infection;
Patients with severe coagulation disorders, a history of drug abuse or taking oral anticoagulants;
Coma or incapacitation;
MRI contraindications (history of cardiovascular and cerebrovascular stent implantation, pacemaker, biostimulator, etc.);
Pregnant women;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
human umbilical cord mesenchymal stem cell suspension2 * 10^7 cells (2ml)	Biological	hUC-MSCs transplantation group
total endoscopic extraction of lumbar nucleus pulposushUC-MSCs are injected into the opposite side of the minimally invasive surgical site immediately after surgery, and the puncture needle remains for 1 minute after injection and then pull out to prevent cell suspension leakage	Procedure or surgery	control group

Primary outcome

Change of lumbar disc MRI (T2WI) signal values
Time frame: 12 months
Lumbar MRI images are taken on day 0-1 (measured before stem cell transplantation), 3 months, 6 months and 12 months to record the signal value of the intervertebral disc (4 times in total) from level IV-V to level III and below.

3 secondary outcomes

Lower back pain and lower extremity radiating pain relief
Time frame: 12 months
X-ray Disc Height Index (DHI)
Time frame: 12 months
MRI highlights changes in the size of the nucleus pulposus
Time frame: 12 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
Individual participant dataSharing planned: No

Related trials for Lumbar Disc Degeneration

Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of lumbar disc MRI (T2WI) signal values (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06589271.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.