Degenerative Disc DiseasePhase 1/2AMSC-DSD-001NCT03827096
Utilization of Autologous Mesenchymal Cells in Posterolateral Spinal Fusion in Degenerative Spine Disease
A Phase 1/2 study testing Suspension of human autologous MSC 3P in 1.5 ml in people with Degenerative Disc Disease, run by Bioinova, s.r.o..
Trial summary
Subjects in whom a posterolateral fusion surgery has been planned and who meet the inclusion and exclusion criteria were proposed to receive a single-dose AMSC treatment, in order to assess its safety and efficacy on posterolateral interbody fusion. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Suspension of human autologous MSC 3P in 1.5 ml
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 27 Aug 2013to 14 Dec 2016
- Phase
- Phase 1/2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- established diagnosis of spinal degenerative disease indicated for lumbar spine surgery,
- patients indicated for fusion therapy,
- patients between 18-55 years, both sexes,
- patients able to provide written informed consent.
Who cannot join
- previous lumbar spine surgery in the same segment of the spine, in order to achieve vertebral fusion,
- osteoporosis,
- diabetes mellitus,
- pregnancy or breastfeeding,
- women of childbearing potential not using effective contraception (established oral contraception, intrauterine device, ligation of the uterine tube) including proven contraceptive measures taken by their sexual partners,
- fertile men not using proven contraceptive measures including effective contraception method in their partner (established oral contraception, intrauterine device, ligation of the uterine tube),
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- coagulopathy,
- malnutrition, primary biliary cirrhosis,
- skin infection at the site of bone marrow aspiration or at the site of spinal fusion,
- gastrostomy,
- any significant medical condition that would compromise the safety of the patient (e.g. recent myocardial infarction, congestive heart failure, renal failure, liver failure, systemic infection, recurrent thromboembolic disease .....),
- alcohol or drug abuse,
- cancer (compulsory clinical oncological screening),
- ongoing or recent (last 3 months) systemic corticosteroid or immunosuppressive therapy.
About this study
Official title: Utilization of Autologous Mesenchymal Cells in Posterolateral Spinal Fusion in Degenerative Spine Disease to Assess the Safety and the Efficacy
Subjects in whom a posterolateral fusion surgery has been planned and who meet the inclusion and exclusion criteria were proposed to receive a single-dose AMSC treatment, in order to assess its safety and efficacy on posterolateral interbody fusion. After the surgery, the subjects were followed up as out-patients during 5 study visits for 12 months in total.
Read the detailed description
Following informed consent collection at the screening visit and verification of all inclusion and exclusion criteria, eligible patients will undergo the procedure of bone marrow cell aspiration from iliac crest for the purpose of receiving autologous multipotent mesenchymal stem cells. The cells will be cultivated for 3 passages (for 3 - 4 weeks) in order to expand them to sufficient quantity. Suspension of the cultured AMSC will then be sterilely packed and transported to the surgery site. During the posterolateral spine fusion operation, 1.5 ml of cell suspension will be mixed with 5 cc of beta-tricalcium phosphate foam (Vitoss™, Orthovita) and 3.5 ml of patient's blood, and inserted between the transverse processes of the lumbar spine.
All subjects will be hospitalized and followed up as per standard medical care rules used in the investigational site hospital for this type of intervention.
- Conditions
- Degenerative Disc Disease
- Being tested
- Suspension of human autologous MSC 3P in 1.5 ml
- 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.
Suspension of human autologous MSC 3P in 1.5 mlDrug
Also called hAMSC
During the posterolateral spine fusion operation, 1.5 ml of cell suspension was mixed with 5cc of beta-tricalcium phosphate foam and 3.5 ml of patient's blood, and inserted between the right transverse processes of the lumbar spine.
| Study group | Role | What they receive |
|---|---|---|
| Human AMSC (passage 3) 3P in 1.5 mL | Experimental | Patient receiving the investigational medicinal product - suspension of human autologous MSC 3P in 1.5 mL Receives: Drug: Suspension of human autologous MSC 3P in 1.5 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: To demonstrate absence of complications at the site of spinal fusion
Complications at the site of spinal fusion and other treatment-related adverse events will be recorded in ten patients at Visits I through VII. All adverse events (AEs) will be classified by seriousness, severity and relationship to hAMSC application.
All AEs will be collected as symptoms spontaneously reported by the patient, clinically relevant changes and abnormalities observed by the Investigator (clinically significant laboratory measurements confirmed by repeated measurement, results of physical examinations) Intensity
The following 3-point rating scale will be used for rating of the intensity of each AE:
Mild: Awareness of signs or symptoms, but no disruption of usual activity Moderate: Event sufficient to affect usual activities (disturbing) Severe: Inability to work or perform usual activities (unacceptable)
Measured: 1 year
Secondary outcomes (3)
Efficacy: To assess the quality of life determined by Oswestry Questionnaire.
The quality of life determined by Oswestry Questionnaire will be recorded in ten patients at Visits II, and IV through VII. The test has 10 sections and maximum score is 50 points; change from the baseline valie will be recorded. The points are then transferred into percentage and interpreted in a standard way when 0-20% means minimal disability while 81-100% means bed-bound condition. Minimum detectable change (90 % confidence) is 10 % (5 points).
Measured: 1 year
Efficacy: To assess the quality of spinal fusion by X-ray imaging
The quality of spinal fusion will be measured by X-ray imaging at Visits V and VII. Dynamic X-ray of the lumbar spine will be performed at 3 and 12 months following the surgery and hAMSC application to measure the angle of the spine movement in the fusion area. The angle will be recorded in degrees. The movements above 10 degrees will beregarded as "unstable".
The bone fusion morphology will be evaluated based on the following scale:
- Cyst or pseudo-cyst formation
- Fusion not visible
- Pseudo-joint (or false joint) development
- Low degree of bone fusion
- High degree of bone fusion
Measured: 1 year
Efficacy: To assess the quality of spinal fusion measured by computed tomography (CT).
The quality of spinal fusion will be measured by CT in ten patients at Visits V and VII.
The density will of the fusion will be expressed as % on a linear scale between two standardized measuring points: soft tissue= 0%, vertebral arch= 100%.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start27 Aug 2013
- Primary completion14 Dec 2016
- Study completion14 Dec 2016
Why it stopped: Primary endpoint (Safety) has been achieved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioinova, s.r.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Motol
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827096
- Sponsor's protocol ID
- AMSC-DSD-001
- Acronym
- AMSC-DSD-001
- Status last verified
- Jan 2020
- First submitted
- 14 Jan 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be published
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Autologous Mesenchymal Cells in Posterolateral Spinal Fusion in Degenerative Spine Disease to Assess the Safety and the Efficacy
- ClinicalTrials.gov ID
- NCT03827096
- Acronym / sponsor ID
- AMSC-DSD-001 / AMSC-DSD-001
- Conditions
- Degenerative Disc Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary endpoint (Safety) has been achieved
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Bioinova, s.r.o.Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Motol
- Study start
- 27 Aug 2013 (actual)
- Primary completion
- 14 Dec 2016 (actual)
- Study completion
- 14 Dec 2016 (actual)
- First posted
- 1 Feb 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.
Subjects in whom a posterolateral fusion surgery has been planned and who meet the inclusion and exclusion criteria were proposed to receive a single-dose AMSC treatment, in order to assess its safety and efficacy on posterolateral interbody fusion. After the surgery, the subjects were followed up as out-patients during 5 study visits for 12 months in total.
Detailed description
Following informed consent collection at the screening visit and verification of all inclusion and exclusion criteria, eligible patients will undergo the procedure of bone marrow cell aspiration from iliac crest for the purpose of receiving autologous multipotent mesenchymal stem cells. The cells will be cultivated for 3 passages (for 3 - 4 weeks) in order to expand them to sufficient quantity. Suspension of the cultured AMSC will then be sterilely packed and transported to the surgery site. During the posterolateral spine fusion operation, 1.5 ml of cell suspension will be mixed with 5 cc of beta-tricalcium phosphate foam (Vitoss™, Orthovita) and 3.5 ml of patient's blood, and inserted between the transverse processes of the lumbar spine.
All subjects will be hospitalized and followed up as per standard medical care rules used in the investigational site hospital for this type of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human AMSC (passage 3) 3P in 1.5 mL | Experimental | Drug: Suspension of human autologous MSC 3P in 1.5 mlPatient receiving the investigational medicinal product - suspension of human autologous MSC 3P in 1.5 mL |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- established diagnosis of spinal degenerative disease indicated for lumbar spine surgery,
- patients indicated for fusion therapy,
- patients between 18-55 years, both sexes,
- patients able to provide written informed consent.
Key exclusion criteria (14 listed)
- previous lumbar spine surgery in the same segment of the spine, in order to achieve vertebral fusion,
- osteoporosis,
- diabetes mellitus,
- pregnancy or breastfeeding,
- women of childbearing potential not using effective contraception (established oral contraception, intrauterine device, ligation of the uterine tube) including proven contraceptive measures taken by their sexual partners,
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 |
|---|---|---|
| Suspension of human autologous MSC 3P in 1.5 mlAlso: hAMSCDuring the posterolateral spine fusion operation, 1.5 ml of cell suspension was mixed with 5cc of beta-tricalcium phosphate foam and 3.5 ml of patient's blood, and inserted between the right transverse processes of the lumbar spine. | Drug | Human AMSC (passage 3) 3P in 1.5 mL |
Primary outcome
Safety: To demonstrate absence of complications at the site of spinal fusion
Time frame: 1 year
Complications at the site of spinal fusion and other treatment-related adverse events will be recorded in ten patients at Visits I through VII. All adverse events (AEs) will be classified by seriousness, severity and relationship to hAMSC application. All AEs will be collected as symptoms spontaneously reported by the patient, clinically relevant changes and abnormalities observed by the Investigator (clinically significant laboratory measurements confirmed by repeated measurement, results of physical examinations) Intensity The following 3-point rating scale will be used for rating of the intensity of each AE: Mild: Awareness of signs or symptoms, but no disruption of usual activity Moderate: Event sufficient to affect usual activities (disturbing) Severe: Inability to work or perform usual activities (unacceptable)
3 secondary outcomes
Efficacy: To assess the quality of life determined by Oswestry Questionnaire.
Time frame: 1 year
Efficacy: To assess the quality of spinal fusion by X-ray imaging
Time frame: 1 year
Efficacy: To assess the quality of spinal fusion measured by computed tomography (CT).
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Primary endpoint (Safety) has been achieved). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: No. The data will be published
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Suspension of human autologous MSC 3P in 1.5 ml in people with Degenerative Disc Disease, run by Bioinova, s.r.o..
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 4 inclusion and 14 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: stopped early, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Primary endpoint (Safety) has been achieved). 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?
Safety: To demonstrate absence of complications at the site of spinal fusion (time frame: 1 year). 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 18 Jan 2020.