Lumbar Discogenic PainPhase 1NCT04104412
The Safety/Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy (19#iSCLife®-LDP) for Lumbar Discogenic Pain
A Phase 1 study testing human umbilical cord mesenchymal stem cell in people with Lumbar Discogenic Pain, run by Sclnow Biotechnology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Discogenic Pain
- What is being tested?
- human umbilical cord mesenchymal stem cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2019to 30 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Jiaxiang Ni, Master, 13901743476, nijiaxiang@yahoo.com
Yuanzhang Tang, Doctor
About this study
Official title: The Safety/Efficacy Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy for Patients With Lumbar Discogenic Pain
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.
Read the 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
- Being tested
- human umbilical cord mesenchymal stem cell
- Keywords
- lumbar discogenic pain, mesenchymal stem cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human umbilical cord mesenchymal stem cellBiological
2*10^7
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 24 weeks
Secondary outcomes (6)
Observe treatment
Secondary measures were assessed at 3, 6, 12 and 24 weeks before and after treatment, including:
Subjective indicators:
ODI(The Oswestry Disability Index) score:
0%-20%: Minimal disability: This group can cope with most living activities. Don't need treatment.
20%-40% Moderate disability: This group experiences more pain and problems with sitting, lifting, and standing. Personal care, sexual activity, and sleeping are not grossly affected, and the back condition can usually be managed by conservative means.
40%-60%: Severe disability: Pain remains the main problem in this group of patients, but travel, personal care, social life, sexual activity, and sleep are also affected.
60%-80%: Crippled: Back pain impinges on all aspects of these patients' lives-both at home and at work-and positive intervention is required.
80%-100%: These patients are either bed-bound or exaggerating their symptoms. Need evaluated by careful observation of the patient during medical examination.
Measured: 24weeks
Safety evaluation by detecting adverse events and serious adverse events
Observe for any adverse reactions, including fever, pain, or bleeding to evaluate the changes of safety indexes at the 3、6、12、24weeks after treatment.
Measured: 24 weeks
Safety evaluation by detecting Activated partial thromboplastin time (APTT)
Being the Activated partial thromboplastin time (APTT) test for the patients to examine the changes of safety indexes at the 3、6、12、24 weeks after treatment.
time of 25-37 seconds. Abnormalities over 10 seconds should be compared with normal controls.
Measured: 24 weeks
Safety evaluation by detecting Prothrombin time (PT)
Being the Prothrombin time (PT) test for the patients to examine the changes of safety indexes at the 3、6、12、24 weeks after treatment.
time of 11-14 seconds. Abnormalities over 3 seconds in comparison with normal controls are required. Activity: 80-120% INR: 0.8-1.2
Measured: 24 weeks
Safety evaluation by detecting Fibrinogen
Fibrinogen test for the patients to examine the changes of safety indexes at the 3、6、12、24 weeks after treatment.
The Fibrinogen should in 2-4g/L
Measured: 24 weeks
Safety evaluation by detecting Thrombin time (TT)
Thrombin time (TT) test for the patients to examine the changes of safety indexes at the 3、6、12、24 weeks after treatment.
the time of 12-16 seconds, TT need to be abnormal for more than 3 seconds compared with normal controls
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start15 Aug 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Discogenic PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sclnow Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuanzhang Tang, Doctor, Study director, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04104412
- Sponsor's protocol ID
- SCLnow-XW-01
- Status last verified
- Dec 2025
- First submitted
- 2 Sep 2019
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety/Efficacy Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy for Patients With Lumbar Discogenic Pain
- ClinicalTrials.gov ID
- NCT04104412
- Acronym / sponsor ID
- SCLnow-XW-01
- Conditions
- Lumbar Discogenic Pain
- Keywords
- lumbar discogenic pain, mesenchymal stem cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Sclnow Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 Sep 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group A （with mesenchymal stem cell intervention） | Experimental | Biological: human umbilical cord mesenchymal stem cellobserve 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 |
| control group B | No intervention | –observe the effectiveness and safety of patients by injecting normal saline and Low temperature plasma vaporization ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (12 listed)
- 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.;
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 cell2*10^7 | Biological | treatment group A （with mesenchymal stem cell intervention） |
Primary outcome
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
Time frame: 24 weeks
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%
6 secondary outcomes
Observe treatment
Time frame: 24weeks
Safety evaluation by detecting adverse events and serious adverse events
Time frame: 24 weeks
Safety evaluation by detecting Activated partial thromboplastin time (APTT)
Time frame: 24 weeks
Safety evaluation by detecting Prothrombin time (PT)
Time frame: 24 weeks
Safety evaluation by detecting Fibrinogen
Time frame: 24 weeks
Safety evaluation by detecting Thrombin time (TT)
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Yuanzhang Tang, Doctor study director
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing human umbilical cord mesenchymal stem cell in people with Lumbar Discogenic Pain, run by Sclnow Biotechnology Co., Ltd. at 1 site in China.
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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 23 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiaxiang Ni, Master (8613910743476, nijiaxiang@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2026.