Lumbar Disc DegenerationNCT04414592
Human Umbilical Cord Mesenchymal Stem Cells For the Treatment of Lumbar Disc Degeneration Disease
A study testing human umbilical cord mesenchymal stem cells in people with Lumbar Disc Degeneration and Lumbar Disc Herniation, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 2 sites in China.
Trial summary
This study aims to investigate the safety and efficiency of Human Umbilical Cord Mesenchymal Stem Cells (hUCMSC) for treating lumbar disc degeneration diseases. We hypothesize grafting hUCMSC into the degenerative disc leads to symptoms relief and slow down the progression of disc degeneration. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lumbar Disc Degeneration, Lumbar Disc Herniation
- What is being tested?
- human umbilical cord mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2020to Mar 2023
- Phase
- Interventional
- 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;
- Symptoms with lower back pain and unilateral radicular pain;
- Failure of conservative treatments including physical therapy, manipulation therapy and non-morphine drug therapy;
- CT/MRI clearly showing unilateral nucleus pulposus herniation to compress the nerve root;
- Symptoms and imaging showing unilateral lumbar disc herniation;
- Imaging showed single-segment lumbar disc herniation;
Show all 11Show fewer
- Pfirrmann disc degeneration classification from lumbar MRI: grade I-IV;
- Segments of lumbar disc herniation: L3-4, L4-5, L5-S1;
- Unilateral full endoscopic lumbar discectomy;
- Signing the informed consent;
- No previous history of spinal surgery.
Who cannot join
- Previous history of tumor or spinal infection;
- Severe coagulation disorders or are taking oral anticoagulants
- coma or incapacity;
- MRI contraindications (cardiovascular and cerebrovascular stent implantation history, cardiac pacemaker, biological stimulator, etc.);
- pregnant;
- pregnancy or breastfeeding;
Show all 22Show fewer
- participated in other clinical trials in the past 30 days;
- History of stem cell therapy;
- poor compliance, or inability to properly understand the coordination;
- received intervertebral disc interventional therapy, such as radiofrequency, laser ablation, protease injection and ozone injection in the past 3 months;
- Highly allergic constitution or severe allergic history;
- Severe autoimmune diseases or receiving immunosuppressive therapy;
- Severe infection or high fever;
- Shock, failure of vital organs or unstable vital signs;
- X-ray showing that the stenosis percentage of the degenerative segment was larger than 30% compared to that of the adjacent normal segment.
- Lumbar disc herniation with calcification;
- Lumbar disc herniation with Modic Change;
- Lumbar disc herniation with severe spinal stenosis;
- Lumbar disc herniation with lumbar spondylolisthesis;
- Lumbar disc herniation with spinal deformity;
- psychosocial abnormalities, cognitive impairment, or other physical diseases affecting the research results;
- Other reasons.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Qiang Fu, M.D., 13636636288, johson.f@163.com
Song Guo, M.D., 15901836457, guosongtj@163.com
- Recruiting
Shanghai General Hospital
Shanghai
Qiang Fu, M.D., 13636636288
Qiang Fu, M.D.
About this study
Official title: Safety and Effectiveness of Human Umbilical Cord Mesenchymal Stem Cells For the Treatment of Lumbar Disc Degeneration Disease
This study aims to investigate the safety and efficiency of Human Umbilical Cord Mesenchymal Stem Cells (hUCMSC) for treating lumbar disc degeneration diseases. We hypothesize grafting hUCMSC into the degenerative disc leads to symptoms relief and slow down the progression of disc degeneration.
Read the detailed description
Lumbar disc herniation causes patients severe lower back pain and radicular pain to decrease the quality of life and lead to great economic burden to patients and society. In recent years, full endoscopic discectomy has been widely used in the treatment of lumbar disc herniation due to its advantages of reduced trauma, enhanced recovery and less cost. However, the reherniation of the residual nucleus pulposus still exist after nerve root decompression. It is urgent to use stem cell and tissue engineering to replace the resection tissue and repair the residual nucleus pulposus for disc resealing. To observe the safety and efficacy of human umbilical cord mesenchymal stem cells (hUCMSCs) in the treatment of lumbar disc degeneration. This clinical trial is aimed to include a single group of 20 patients with lumbar disc herniation. Twenty million hUCMSCs will be injected into the lumbar disc of the enrolled patients in this non-random, self-controlled and single-dose open study design. The patients will be followed up for 3 months, 6 months and 12 months after the injection to evaluate the safety of the patients after grafting hUCMSCs. Additionally, improvement of patients' quality of life will be evaluated using the ODI score, VAS score and SF-36 score. Lumbar disc signals will be also quantified using MRI to demonstrate hUCMSCs transplantation could slow down lumbar disc degeneration.
- Conditions
- Lumbar Disc Degeneration, Lumbar Disc Herniation
- Being tested
- human umbilical cord mesenchymal stem cells
- Keywords
- Lumbar Disc Degeneration, Human Umbilical Cord Mesenchymal Stem Cells, Lumbar Disc Herniation
- Medical subject headings
- Intervertebral Disc Degeneration, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human umbilical cord mesenchymal stem cellsOther
Twenty million human umbilical cord mesenchymal stem cells will be immediately injected into the degenerative discs of such patients who are diagnosed with lumbar disc herniation and operated with full endoscopy lumbar discectomy.
| Study group | Role | What they receive |
|---|---|---|
| Human Umbilical Cord Mesenchymal Stem Cells | Experimental | Injection of twenty million human umbilical cord mesenchymal stem cells into the degenerative disc Receives: Other: human umbilical cord mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar disc signaling values from magnetic resonance imaging
Changes from baseline in Lumbar disc signaling values from magnetic resonance imaging
Measured: Baseline, post-op 3months, post-op 6months, post-op 12months
Secondary outcomes (6)
Visual Analogue Scale (VAS) (0-10 scores, the higher scores mean a worse outcome)
Changes from baseline in Visual Analogue Scale of Lower back pain and leg pain
Measured: Baseline, post-op 3months, post-op 6months, post-op 12months
Oswestry Disability Index(ODI) (0-50 scores, the higher scores mean a worse outcome)
Changes from baseline in Oswestry Disability Index
Measured: Baseline, post-op 3months, post-op 6months, post-op 12months
The Short Form (36) Health survey (SF36) (0-100 scores, the higher scores mean a better outcome)
Changes from baseline in The Short Form (36) Health survey (SF36)
Measured: Baseline, post-op 3months, post-op 6months, post-op 12months
Disc Height Index (DHI) from X ray
Changes from baseline in Disc Height Index
Measured: Baseline, post-op 3months, post-op 6months, post-op 12months
Size of herniated nucleus pulposus from magnetic resonance imaging
Changes from baseline in size of nucleus pulposus from magnetic resonance imaging
Measured: Baseline, post-op 3months, post-op 6months, post-op 12months
Number of participants with treatment-related adverse events by CTCAE v4.0
Assessing for worsening of patients' baseline symptoms or functions (will be considered an AE); (also general AE events), particular AE events related to the procedures/treatment. All AEs will be assessed by common terminology criteria for adverse events.
Measured: From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study startAug 2020 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc DegenerationStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang Fu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Qiang Fu, M.D., Principal investigator, Minimally Invasive Spinal of Shanghai General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414592
- Sponsor's protocol ID
- QFu
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the relative individual participant data (IPD) collected during the trial after deidentification
Publications
Walker BF. The prevalence of low back pain: a systematic review of the literature from 1966 to 1998. J Spinal Disord. 2000 Jun;13(3):205-17. doi: 10.1097/00002517-200006000-00003.
PubMed 10872758Ghiselli G, Wang JC, Bhatia NN, Hsu WK, Dawson EG. Adjacent segment degeneration in the lumbar spine. J Bone Joint Surg Am. 2004 Jul;86(7):1497-503. doi: 10.2106/00004623-200407000-00020.
PubMed 15252099Chen Z, Zhang L, Dong J, Xie P, Liu B, Wang Q, Chen R, Shu T, Li S, Feng F, Yang B, He L, Yang Y, Liu Z, Pang M, Rong L. Percutaneous Transforaminal Endoscopic Discectomy Versus Microendoscopic Discectomy for Lumbar Disc Herniation: Two-Year Results of a Randomized Controlled Trial. Spine (Phila Pa 1976). 2020 Apr 15;45(8):493-503. doi: 10.1097/BRS.0000000000003314.
PubMed 31703056Li Z, Lang G, Chen X, Sacks H, Mantzur C, Tropp U, Mader KT, Smallwood TC, Sammon C, Richards RG, Alini M, Grad S. Polyurethane scaffold with in situ swelling capacity for nucleus pulposus replacement. Biomaterials. 2016 Apr;84:196-209. doi: 10.1016/j.biomaterials.2016.01.040. Epub 2016 Jan 21.
PubMed 26828684Moriguchi Y, Mojica-Santiago J, Grunert P, Pennicooke B, Berlin C, Khair T, Navarro-Ramirez R, Ricart Arbona RJ, Nguyen J, Hartl R, Bonassar LJ. Total disc replacement using tissue-engineered intervertebral discs in the canine cervical spine. PLoS One. 2017 Oct 20;12(10):e0185716. doi: 10.1371/journal.pone.0185716. eCollection 2017.
PubMed 29053719Benneker LM, Andersson G, Iatridis JC, Sakai D, Hartl R, Ito K, Grad S. Cell therapy for intervertebral disc repair: advancing cell therapy from bench to clinics. Eur Cell Mater. 2014 May 6;27:5-11. doi: 10.22203/ecm.v027sa02.
PubMed 24802611Sobajima S, Vadala G, Shimer A, Kim JS, Gilbertson LG, Kang JD. Feasibility of a stem cell therapy for intervertebral disc degeneration. Spine J. 2008 Nov-Dec;8(6):888-96. doi: 10.1016/j.spinee.2007.09.011. Epub 2007 Dec 21.
PubMed 18082460Sakai D, Mochida J, Yamamoto Y, Nomura T, Okuma M, Nishimura K, Nakai T, Ando K, Hotta T. Transplantation of mesenchymal stem cells embedded in Atelocollagen gel to the intervertebral disc: a potential therapeutic model for disc degeneration. Biomaterials. 2003 Sep;24(20):3531-41. doi: 10.1016/s0142-9612(03)00222-9.
PubMed 12809782Sakai D, Mochida J, Iwashina T, Hiyama A, Omi H, Imai M, Nakai T, Ando K, Hotta T. Regenerative effects of transplanting mesenchymal stem cells embedded in atelocollagen to the degenerated intervertebral disc. Biomaterials. 2006 Jan;27(3):335-45. doi: 10.1016/j.biomaterials.2005.06.038. Epub 2005 Aug 19.
PubMed 16112726Sakai D, Mochida J, Iwashina T, Watanabe T, Nakai T, Ando K, Hotta T. Differentiation of mesenchymal stem cells transplanted to a rabbit degenerative disc model: potential and limitations for stem cell therapy in disc regeneration. Spine (Phila Pa 1976). 2005 Nov 1;30(21):2379-87. doi: 10.1097/01.brs.0000184365.28481.e3.
PubMed 16261113Crevensten G, Walsh AJ, Ananthakrishnan D, Page P, Wahba GM, Lotz JC, Berven S. Intervertebral disc cell therapy for regeneration: mesenchymal stem cell implantation in rat intervertebral discs. Ann Biomed Eng. 2004 Mar;32(3):430-4. doi: 10.1023/b:abme.0000017545.84833.7c.
PubMed 15095817Zhang YG, Guo X, Xu P, Kang LL, Li J. Bone mesenchymal stem cells transplanted into rabbit intervertebral discs can increase proteoglycans. Clin Orthop Relat Res. 2005 Jan;(430):219-26. doi: 10.1097/01.blo.0000146534.31120.cf.
PubMed 15662327Ho G, Leung VY, Cheung KM, Chan D. Effect of severity of intervertebral disc injury on mesenchymal stem cell-based regeneration. Connect Tissue Res. 2008;49(1):15-21. doi: 10.1080/03008200701818595.
PubMed 18293174Yi Z, Guanjun T, Lin C, Zifeng P. Effects of Transplantation of hTIMP-1-Expressing Bone Marrow Mesenchymal Stem Cells on the Extracellular Matrix of Degenerative Intervertebral Discs in an In Vivo Rabbit Model. Spine (Phila Pa 1976). 2014 May 15;39(11):E669-E675. doi: 10.1097/BRS.0000000000000316.
PubMed 24718065Wei A, Tao H, Chung SA, Brisby H, Ma DD, Diwan AD. The fate of transplanted xenogeneic bone marrow-derived stem cells in rat intervertebral discs. J Orthop Res. 2009 Mar;27(3):374-9. doi: 10.1002/jor.20567.
PubMed 18853431
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Human Umbilical Cord Mesenchymal Stem Cells For the Treatment of Lumbar Disc Degeneration Disease
- ClinicalTrials.gov ID
- NCT04414592
- Acronym / sponsor ID
- QFu
- Conditions
- Lumbar Disc Degeneration, Lumbar Disc Herniation
- Keywords
- Lumbar Disc Degeneration, Human Umbilical Cord Mesenchymal Stem Cells, Lumbar Disc Herniation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 4 Jun 2020 (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 study aims to investigate the safety and efficiency of Human Umbilical Cord Mesenchymal Stem Cells (hUCMSC) for treating lumbar disc degeneration diseases. We hypothesize grafting hUCMSC into the degenerative disc leads to symptoms relief and slow down the progression of disc degeneration.
Detailed description
Lumbar disc herniation causes patients severe lower back pain and radicular pain to decrease the quality of life and lead to great economic burden to patients and society. In recent years, full endoscopic discectomy has been widely used in the treatment of lumbar disc herniation due to its advantages of reduced trauma, enhanced recovery and less cost. However, the reherniation of the residual nucleus pulposus still exist after nerve root decompression. It is urgent to use stem cell and tissue engineering to replace the resection tissue and repair the residual nucleus pulposus for disc resealing. To observe the safety and efficacy of human umbilical cord mesenchymal stem cells (hUCMSCs) in the treatment of lumbar disc degeneration. This clinical trial is aimed to include a single group of 20 patients with lumbar disc herniation. Twenty million hUCMSCs will be injected into the lumbar disc of the enrolled patients in this non-random, self-controlled and single-dose open study design. The patients will be followed up for 3 months, 6 months and 12 months after the injection to evaluate the safety of the patients after grafting hUCMSCs. Additionally, improvement of patients' quality of life will be evaluated using the ODI score, VAS score and SF-36 score. Lumbar disc signals will be also quantified using MRI to demonstrate hUCMSCs transplantation could slow down lumbar disc degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human Umbilical Cord Mesenchymal Stem Cells | Experimental | Other: human umbilical cord mesenchymal stem cellsInjection of twenty million human umbilical cord mesenchymal stem cells into the degenerative disc |
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;
- Symptoms with lower back pain and unilateral radicular pain;
- Failure of conservative treatments including physical therapy, manipulation therapy and non-morphine drug therapy;
- CT/MRI clearly showing unilateral nucleus pulposus herniation to compress the nerve root;
- Symptoms and imaging showing unilateral lumbar disc herniation;
Key exclusion criteria (22 listed)
- Previous history of tumor or spinal infection;
- Severe coagulation disorders or are taking oral anticoagulants
- coma or incapacity;
- MRI contraindications (cardiovascular and cerebrovascular stent implantation history, cardiac pacemaker, biological stimulator, etc.);
- pregnant;
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 cellsTwenty million human umbilical cord mesenchymal stem cells will be immediately injected into the degenerative discs of such patients who are diagnosed with lumbar disc herniation and operated with full endoscopy lumbar discectomy. | Other | Human Umbilical Cord Mesenchymal Stem Cells |
Primary outcome
Lumbar disc signaling values from magnetic resonance imaging
Time frame: Baseline, post-op 3months, post-op 6months, post-op 12months
Changes from baseline in Lumbar disc signaling values from magnetic resonance imaging
6 secondary outcomes
Visual Analogue Scale (VAS) (0-10 scores, the higher scores mean a worse outcome)
Time frame: Baseline, post-op 3months, post-op 6months, post-op 12months
Oswestry Disability Index(ODI) (0-50 scores, the higher scores mean a worse outcome)
Time frame: Baseline, post-op 3months, post-op 6months, post-op 12months
The Short Form (36) Health survey (SF36) (0-100 scores, the higher scores mean a better outcome)
Time frame: Baseline, post-op 3months, post-op 6months, post-op 12months
Disc Height Index (DHI) from X ray
Time frame: Baseline, post-op 3months, post-op 6months, post-op 12months
Size of herniated nucleus pulposus from magnetic resonance imaging
Time frame: Baseline, post-op 3months, post-op 6months, post-op 12months
Number of participants with treatment-related adverse events by CTCAE v4.0
Time frame: From baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Background: PubMed 10872758Walker BF. The prevalence of low back pain: a systematic review of the literature from 1966 to 1998. J Spinal Disord. 2000 Jun;13(3):205-17. doi: 10.1097/00002517-200006000-00003.
- Background: PubMed 15252099Ghiselli G, Wang JC, Bhatia NN, Hsu WK, Dawson EG. Adjacent segment degeneration in the lumbar spine. J Bone Joint Surg Am. 2004 Jul;86(7):1497-503. doi: 10.2106/00004623-200407000-00020.
- Background: PubMed 31703056Chen Z, Zhang L, Dong J, Xie P, Liu B, Wang Q, Chen R, Shu T, Li S, Feng F, Yang B, He L, Yang Y, Liu Z, Pang M, Rong L. Percutaneous Transforaminal Endoscopic Discectomy Versus Microendoscopic Discectomy for Lumbar Disc Herniation: Two-Year Results of a Randomized Controlled Trial. Spine (Phila Pa 1976). 2020 Apr 15;45(8):493-503. doi: 10.1097/BRS.0000000000003314.
- Background: PubMed 26828684Li Z, Lang G, Chen X, Sacks H, Mantzur C, Tropp U, Mader KT, Smallwood TC, Sammon C, Richards RG, Alini M, Grad S. Polyurethane scaffold with in situ swelling capacity for nucleus pulposus replacement. Biomaterials. 2016 Apr;84:196-209. doi: 10.1016/j.biomaterials.2016.01.040. Epub 2016 Jan 21.
- Background: PubMed 29053719Moriguchi Y, Mojica-Santiago J, Grunert P, Pennicooke B, Berlin C, Khair T, Navarro-Ramirez R, Ricart Arbona RJ, Nguyen J, Hartl R, Bonassar LJ. Total disc replacement using tissue-engineered intervertebral discs in the canine cervical spine. PLoS One. 2017 Oct 20;12(10):e0185716. doi: 10.1371/journal.pone.0185716. eCollection 2017.
- Background: PubMed 24802611Benneker LM, Andersson G, Iatridis JC, Sakai D, Hartl R, Ito K, Grad S. Cell therapy for intervertebral disc repair: advancing cell therapy from bench to clinics. Eur Cell Mater. 2014 May 6;27:5-11. doi: 10.22203/ecm.v027sa02.
- Background: PubMed 18082460Sobajima S, Vadala G, Shimer A, Kim JS, Gilbertson LG, Kang JD. Feasibility of a stem cell therapy for intervertebral disc degeneration. Spine J. 2008 Nov-Dec;8(6):888-96. doi: 10.1016/j.spinee.2007.09.011. Epub 2007 Dec 21.
- Background: PubMed 12809782Sakai D, Mochida J, Yamamoto Y, Nomura T, Okuma M, Nishimura K, Nakai T, Ando K, Hotta T. Transplantation of mesenchymal stem cells embedded in Atelocollagen gel to the intervertebral disc: a potential therapeutic model for disc degeneration. Biomaterials. 2003 Sep;24(20):3531-41. doi: 10.1016/s0142-9612(03)00222-9.
- Background: PubMed 16112726Sakai D, Mochida J, Iwashina T, Hiyama A, Omi H, Imai M, Nakai T, Ando K, Hotta T. Regenerative effects of transplanting mesenchymal stem cells embedded in atelocollagen to the degenerated intervertebral disc. Biomaterials. 2006 Jan;27(3):335-45. doi: 10.1016/j.biomaterials.2005.06.038. Epub 2005 Aug 19.
- Background: PubMed 16261113Sakai D, Mochida J, Iwashina T, Watanabe T, Nakai T, Ando K, Hotta T. Differentiation of mesenchymal stem cells transplanted to a rabbit degenerative disc model: potential and limitations for stem cell therapy in disc regeneration. Spine (Phila Pa 1976). 2005 Nov 1;30(21):2379-87. doi: 10.1097/01.brs.0000184365.28481.e3.
- Background: PubMed 15095817Crevensten G, Walsh AJ, Ananthakrishnan D, Page P, Wahba GM, Lotz JC, Berven S. Intervertebral disc cell therapy for regeneration: mesenchymal stem cell implantation in rat intervertebral discs. Ann Biomed Eng. 2004 Mar;32(3):430-4. doi: 10.1023/b:abme.0000017545.84833.7c.
- Background: PubMed 15662327Zhang YG, Guo X, Xu P, Kang LL, Li J. Bone mesenchymal stem cells transplanted into rabbit intervertebral discs can increase proteoglycans. Clin Orthop Relat Res. 2005 Jan;(430):219-26. doi: 10.1097/01.blo.0000146534.31120.cf.
- Individual participant dataSharing planned: Yes. All the relative individual participant data (IPD) collected during the trial after deidentification
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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. This study is not recruiting at the moment.
Qiang Fu, M.D. principal investigator
Minimally Invasive Spinal of Shanghai General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing human umbilical cord mesenchymal stem cells in people with Lumbar Disc Degeneration and Lumbar Disc Herniation, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 2 sites 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 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: status not confirmed, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Contact Song Guo, M.D. (15901836457, guosongtj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumbar disc signaling values from magnetic resonance imaging (time frame: Baseline, post-op 3months, post-op 6months, post-op 12months). 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 NCT04414592, which also lists 27 linked publications.
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 4 Jun 2020.