Spinal Cord InjuriesPhase 1NCT04288934
Treatment of Spinal Cord Injuries With (AutoBM-MSCs)vs (WJ-MSCs).
A Phase 1 study testing Collection and expansion of BM-MSC and VI-SCI evaluation and patients' follow up in people with Spinal Cord Injuries, run by University of Jordan at 1 site in Jordan.
Trial summary
This study aims to assess and compare the safety and effectiveness of Autologous Bone Marrow-Derived MSCs (AutoBM-MSCs) in one group(group A) of SCI who are unlikely to be able to walk independently without treatment after 1 year of SCI, in the other group (group B) to assess the second group of Wharton Jelly derived… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Collection and expansion of BM-MSC and VI-SCI evaluation and patients' follow up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteJordan
- Study dates
- 15 Aug 2017to 20 Sep 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-70 years
- Complete SCI grade AIS-A or -B, or incomplete C
- SCI between cervical levels C5 and thoracic level T11
- At least 12 weeks since time of injury
- Prediction rule score of 10 or less
- Cognitively unaffected
- Motivated for stem cell transplantation
Who cannot join
- Reduced cognition
- Age under 18 years or above 70 years
- Significant osteoporosis in spine and/or joints
- Pregnancy (Adequate contraceptive use is required for women in fertile age)
- Anoxic brain injury
- Neurodegenerative diseases
Show all 14Show fewer
- Evidence of meningitis
- Positive serology for HIV, HBV, HCV, or Syphilis.
- Medical Complications that contraindicate surgery, including major respiratory complications.
- Use of metal implants close to vascular structures (such as cardiac pacemaker or prosthesis) that contraindicate MRI.
- Other medical conditions which can interfere with stem cell transplantation
- Inability to provide informed consent.
- Uncorrected vision
- Cardiac abnormalities and uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Spinal Cord Injury (SCI) Patients.
This study aims to assess and compare the safety and effectiveness of Autologous Bone Marrow-Derived MSCs (AutoBM-MSCs) in one group(group A) of SCI who are unlikely to be able to walk independently without treatment after 1 year of SCI, in the other group (group B) to assess the second group of Wharton Jelly derived mesenchymal stem cells ( WJ-MSCs) in the treatment of acute and subacute spinal cord injury (SCI) patients.
Read the detailed description
The study will be directed by the Cell Therapy Center (CTC) in Jordan, where 20 SCI patients meeting the inclusion criteria will be recruited and divided according to the type of injury into two groups; Group A for patients with complete transection of the spinal cord, and Group B for SCI without a total transaction,10 patients will receive (AutoBM-MSCs)and the other 10 patients with acute and subacute spinal cord injury will receive(WJ-MSCs) by a specialized spine surgeon into the spinal medulla. The outcomes and improvements will be assessed using the American Spinal Injury Association (ASIA) Impairment Scale (AIS) and the Spinal Cord Independence Measure (SCIM) version III, in addition to blood tests, MRI, and somatosensory evoked potential (SSEP).
- Conditions
- Spinal Cord Injuries
- Being tested
- Collection and expansion of BM-MSC, VI-SCI evaluation and patients' follow up
- Keywords
- Spinal cord injuries, Mesenchymal Stem Cells, Allogenic, Bone marrow derived Mesenchymal stem cells, American Spinal Injury Association Impairment Scale
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection and expansion of BM-MSCBiological
MSCs collection from patients owns marrow using a volume of 20 ml of bone marrow obtained from iliac crest of SCI patients under local anesthesia. Manipulations of blood and bone marrow are to be done according to Good Laboratory Practice (GLP) using the gradient sedimentation method.
VI-SCI evaluation and patients' follow upDiagnostic test
- At 6, and 12 months post MSCs transplantation, patients' spine will be imaged using 3 Tesla MRI and compared to baseline.
- The (ASIA)/(ISNCSCI) score will be repeated every 3 months to evaluate any motor or neurological changes
- The Spinal Cord Independence Measure (SCIM III) score will be repeated every 3 months to evaluate the effect on daily activities.
- Blood samples will be withdrawn from patients at 3 months interval for biomarkers detection.
| Study group | Role | What they receive |
|---|---|---|
| patients with complete transection of the spinal cord | Active comparator | This group of patients with complete transection of the spinal cord group will then be subdivided into 2 subgroups with of 5 patients each; the 1st subgroup will be the patients with chronic SCI and the 2nd subgroup will be for the patients with subacute SCI. All patients will receive AutoBM-MSCs by a specialized spine surgeon into the spinal medulla. Receives: Biological: Collection and expansion of BM-MSC; Diagnostic Test: VI-SCI evaluation and patients' follow up |
| patients with SCI without total transaction. | Active comparator | This group will then be subdivided into 2 subgroups with of 5 patients each; the 1st subgroup will be the patients with chronic SCI and the 2nd subgroup will be for the patients with subacute SCI. All patients will receive WJ-MSCs by a specialized spine surgeon into the spinal medulla. Receives: Biological: Collection and expansion of BM-MSC; Diagnostic Test: VI-SCI evaluation and patients' follow up |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCI evaluation and patients follow up
the (ASIA)/(ISNCSCI) to evaluate any motor or neurological changes, and the spinal cord independence measure (SCIM III) score to evaluate the effect on daily activities .these tests will be repeated every 3 months.
blood samples will be withdrawn from patients as well to detect any biomarkers.
Measured: 3 months
SCI evaluation and MSCs transplantation
post MSCs transplantation, patients' spine will be imaged using 3 Tesla MRI and compared to baseline.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start15 Aug 2017
- Primary completion15 Apr 2020
- Study completion20 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Patients with complete transection of the spinal cord. Each group will then be subdivided into 2 subgroups with of 5 patients each; the 1st subgroup will be the patients with chronic SCI and the 2nd subgroup will be for the patients with subacute SCI.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatima Jamali, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288934
- Sponsor's protocol ID
- SCICTC
- Status last verified
- Aug 2021
- First submitted
- 23 Sep 2019
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Effectiveness of Mesenchymal Stem Cells in the Treatment of Spinal Cord Injury (SCI) Patients.
- ClinicalTrials.gov ID
- NCT04288934
- Acronym / sponsor ID
- SCICTC
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal cord injuries, Mesenchymal Stem Cells, Allogenic, Bone marrow derived Mesenchymal stem cells, American Spinal Injury Association Impairment Scale
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 15 Aug 2017 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 28 Feb 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 assess and compare the safety and effectiveness of Autologous Bone Marrow-Derived MSCs (AutoBM-MSCs) in one group(group A) of SCI who are unlikely to be able to walk independently without treatment after 1 year of SCI, in the other group (group B) to assess the second group of Wharton Jelly derived mesenchymal stem cells ( WJ-MSCs) in the treatment of acute and subacute spinal cord injury (SCI) patients.
Detailed description
The study will be directed by the Cell Therapy Center (CTC) in Jordan, where 20 SCI patients meeting the inclusion criteria will be recruited and divided according to the type of injury into two groups; Group A for patients with complete transection of the spinal cord, and Group B for SCI without a total transaction,10 patients will receive (AutoBM-MSCs)and the other 10 patients with acute and subacute spinal cord injury will receive(WJ-MSCs) by a specialized spine surgeon into the spinal medulla. The outcomes and improvements will be assessed using the American Spinal Injury Association (ASIA) Impairment Scale (AIS) and the Spinal Cord Independence Measure (SCIM) version III, in addition to blood tests, MRI, and somatosensory evoked potential (SSEP).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with complete transection of the spinal cord. Each group will then be subdivided into 2 subgroups with of 5 patients each; the 1st subgroup will be the patients with chronic SCI and the 2nd subgroup will be for the patients with subacute SCI.
| Arm | Type | Receives |
|---|---|---|
| patients with complete transection of the spinal cord | Active comparator | Biological: Collection and expansion of BM-MSC, Diagnostic Test: VI-SCI evaluation and patients' follow upThis group of patients with complete transection of the spinal cord group will then be subdivided into 2 subgroups with of 5 patients each; the 1st subgroup will be the patients with chronic SCI and the 2nd subgroup will be for the patients with subacute SCI. All patients will receive AutoBM-MSCs by a specialized spine surgeon into the spinal medulla. |
| patients with SCI without total transaction. | Active comparator | Biological: Collection and expansion of BM-MSC, Diagnostic Test: VI-SCI evaluation and patients' follow upThis group will then be subdivided into 2 subgroups with of 5 patients each; the 1st subgroup will be the patients with chronic SCI and the 2nd subgroup will be for the patients with subacute SCI. All patients will receive WJ-MSCs by a specialized spine surgeon into the spinal medulla. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 18-70 years
- Complete SCI grade AIS-A or -B, or incomplete C
- SCI between cervical levels C5 and thoracic level T11
- At least 12 weeks since time of injury
- Prediction rule score of 10 or less
Key exclusion criteria (14 listed)
- Reduced cognition
- Age under 18 years or above 70 years
- Significant osteoporosis in spine and/or joints
- Pregnancy (Adequate contraceptive use is required for women in fertile age)
- Anoxic brain injury
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 |
|---|---|---|
| Collection and expansion of BM-MSCMSCs collection from patients owns marrow using a volume of 20 ml of bone marrow obtained from iliac crest of SCI patients under local anesthesia. Manipulations of blood and bone marrow are to be done according to Good Laboratory Practice (GLP) using the gradient sedimentation method. | Biological | patients with SCI without total transaction., patients with complete transection of the spinal cord |
| VI-SCI evaluation and patients' follow up* At 6, and 12 months post MSCs transplantation, patients' spine will be imaged using 3 Tesla MRI and compared to baseline. * The (ASIA)/(ISNCSCI) score will be repeated every 3 months to evaluate any motor or neurological changes * The Spinal Cord Independence Measure (SCIM III) score will be repeated every 3 months to evaluate the effect on daily activities. * Blood samples will be withdrawn from patients at 3 months interval for biomarkers detection. | Diagnostic test | patients with SCI without total transaction., patients with complete transection of the spinal cord |
Primary outcome
SCI evaluation and patients follow up
Time frame: 3 months
the (ASIA)/(ISNCSCI) to evaluate any motor or neurological changes, and the spinal cord independence measure (SCIM III) score to evaluate the effect on daily activities .these tests will be repeated every 3 months. blood samples will be withdrawn from patients as well to detect any biomarkers.
SCI evaluation and MSCs transplantation
Time frame: 6-12 months
post MSCs transplantation, patients' spine will be imaged using 3 Tesla MRI and compared to baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
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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.
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 Collection and expansion of BM-MSC and VI-SCI evaluation and patients' follow up in people with Spinal Cord Injuries, run by University of Jordan at 1 site in Jordan.
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 7 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: finished, as of the sponsor's last update on 25 Aug 2021. 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 Jordan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SCI evaluation and patients follow up (time frame: 3 months). The study lists 2 primary outcomes in all. 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 25 Aug 2021.