Spinal Cord InjuriesPhase 1/2NCT02981576
Safety and Effectiveness of BM-MSC vs AT-MSC in the Treatment of SCI Patients.
A Phase 1/2 study testing Autologous Mesenchymal Stem Cells in people with Spinal Cord Injuries, run by University of Jordan at 1 site in Jordan.
Trial summary
Spinal Cord Injury (SCI) is a devastating condition that leads to permanent functional and neurological deficits in injured individuals. The limited ability of the Central Nervous System (CNS) to spontaneously regenerate impairs axonal regeneration and functional recovery of the spinal cord. 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?
- Autologous Mesenchymal Stem Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteJordan
- Study dates
- Nov 2016to 20 Jan 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complete spinal cord injury grade AIS-A or -B, or incomplete C
- At least 2 weeks since time of injury
- Cognitively unaffected
- Motivated for stem cell transplantation
Who cannot join
- Reduced cognition
- Age under 18 years of 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 12Show fewer
- Evidence of meningitis
- Positive serology for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (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 Magnetic resonance imaging (MRI).
- Other medical conditions which can interfere with stem cell transplantation
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Safety and Effectiveness of Autologous Bone Marrow Derived Mesenchymal Stem Cells (BM-MSC) vs Adipose Tissue Derived Mesenchymal Stem Cells (AT-MSC) in the Treatment of Spinal Cord Injury (SCI) Patient.
Spinal Cord Injury (SCI) is a devastating condition that leads to permanent functional and neurological deficits in injured individuals. The limited ability of the Central Nervous System (CNS) to spontaneously regenerate impairs axonal regeneration and functional recovery of the spinal cord. The leading causes are motor-vehicle crashes, sports-associated accidents, falls, and violence-related injuries.
Unfortunately, there is still no effective clinical treatment for SCI. In recent years, tissue engineering and regenerative medicine based approaches have been proposed as alternatives for SCI repair/regeneration. Mesnchymal stem cells (MSC) use in SCI showed promising results in several studies. Our aim is to assess and compare the safety and effectiveness of autologous BM-MSC vs autologous AT-MSC in these patients.
Read the detailed description
The study will be conducted at Cell Therapy Center (CTC) in Jordan, where 14 SCI patients meeting the inclusion criteria will be recruited and blindly divided into 2 groups of equal numbers. The first groups will be treated with autologous BM-MSC, while the second group will be treated with autologous AT-MSC. The outcomes and improvements will be assessed using the American Spinal Injury Association (ASIA) Impairment Scale (AIS). Magnetic Resonance Imaging (MRI) will be performed at base line and after 12 months of the stem cell transplantation.
- Conditions
- Spinal Cord Injuries
- Being tested
- Autologous Mesenchymal Stem Cells
- Keywords
- Spinal Cord Injury, Mesenchymal Stem Cells
- 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.
Autologous Mesenchymal Stem CellsBiological
Autologous Mesenchymal Stem Cells will be collected from patients, prepared in the lab and then injected intrathecally.
| Study group | Role | What they receive |
|---|---|---|
| Recipient of AT-MSC | Active comparator | Patients who will receive Autologous Mesenchymal Stem Cells from AdiposeTissue by Intrathecal injection of stem cells that will be performed 3 times. Receives: Biological: Autologous Mesenchymal Stem Cells |
| Recipient of BM-MSC | Active comparator | Patients who will receive Autologous Mesenchymal Stem Cells from Bone marrow by Intrathecal injection of stem cells that will be performed 3 times. Receives: Biological: Autologous Mesenchymal Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the number of side effects and the improvement on ASIA Impairment score between SCI patients receiving autologous AT-MSC vs BM-MSC.
Comparing the number of SCI patients with any relevant side effects observed and the measured outcome in each arm by follow up Magnetic Resonance Imaging (MRI) and clinical signs and symptoms using ASIA scoring system..
Measured: 12 months
Secondary outcomes (4)
Investigating the number of side effects in SCI patients receiving autologous BM-MSC.
Assessing the number of SCI patients with any relevant side effects observed.
Measured: 12 months
Investigating the effectiveness of autologous BM-MSC in treating SCI patients.
Assessing the therapeutic benefits of the injected Autologous BM-MSC by follow up Magnetic Resonance Imaging (MRI) and clinical signs and symptoms using ASIA scoring system.
Measured: 12 months
Investigating the number of side effects in SCI patients receiving autologous AT-MSC.
Assessing the number of SCI patients with any relevant side effects observed.
Measured: 12 months
Investigating the effectiveness of autologous AT-MSC in treating SCI patients.
Assessing the therapeutic benefits of the injected Autologous AT-MSC by follow up Magnetic Resonance Imaging (MRI) and clinical signs and symptoms using ASIA scoring system.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion5 May 2018
- Study completion20 Jan 2019
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 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
- Investigators
- Abdalla Awidi, MD, Study chair, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981576
- Sponsor's protocol ID
- SCIUJCTC
- Status last verified
- Sep 2019
- First submitted
- 1 Dec 2016
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Safety and Effectiveness of Autologous Bone Marrow Derived Mesenchymal Stem Cells (BM-MSC) vs Adipose Tissue Derived Mesenchymal Stem Cells (AT-MSC) in the Treatment of Spinal Cord Injury (SCI) Patient.
- ClinicalTrials.gov ID
- NCT02981576
- Acronym / sponsor ID
- SCIUJCTC
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injury, Mesenchymal Stem Cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 5 May 2018 (actual)
- Study completion
- 20 Jan 2019 (actual)
- First posted
- 5 Dec 2016 (estimated)
- 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.
Spinal Cord Injury (SCI) is a devastating condition that leads to permanent functional and neurological deficits in injured individuals. The limited ability of the Central Nervous System (CNS) to spontaneously regenerate impairs axonal regeneration and functional recovery of the spinal cord. The leading causes are motor-vehicle crashes, sports-associated accidents, falls, and violence-related injuries.
Unfortunately, there is still no effective clinical treatment for SCI. In recent years, tissue engineering and regenerative medicine based approaches have been proposed as alternatives for SCI repair/regeneration. Mesnchymal stem cells (MSC) use in SCI showed promising results in several studies. Our aim is to assess and compare the safety and effectiveness of autologous BM-MSC vs autologous AT-MSC in these patients.
Detailed description
The study will be conducted at Cell Therapy Center (CTC) in Jordan, where 14 SCI patients meeting the inclusion criteria will be recruited and blindly divided into 2 groups of equal numbers. The first groups will be treated with autologous BM-MSC, while the second group will be treated with autologous AT-MSC. The outcomes and improvements will be assessed using the American Spinal Injury Association (ASIA) Impairment Scale (AIS). Magnetic Resonance Imaging (MRI) will be performed at base line and after 12 months of the stem cell transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recipient of AT-MSC | Active comparator | Biological: Autologous Mesenchymal Stem CellsPatients who will receive Autologous Mesenchymal Stem Cells from AdiposeTissue by Intrathecal injection of stem cells that will be performed 3 times. |
| Recipient of BM-MSC | Active comparator | Biological: Autologous Mesenchymal Stem CellsPatients who will receive Autologous Mesenchymal Stem Cells from Bone marrow by Intrathecal injection of stem cells that will be performed 3 times. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Complete spinal cord injury grade AIS-A or -B, or incomplete C
- At least 2 weeks since time of injury
- Cognitively unaffected
- Motivated for stem cell transplantation
Key exclusion criteria (12 listed)
- Reduced cognition
- Age under 18 years of 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 |
|---|---|---|
| Autologous Mesenchymal Stem CellsAutologous Mesenchymal Stem Cells will be collected from patients, prepared in the lab and then injected intrathecally. | Biological | Recipient of AT-MSC, Recipient of BM-MSC |
Primary outcome
Comparing the number of side effects and the improvement on ASIA Impairment score between SCI patients receiving autologous AT-MSC vs BM-MSC.
Time frame: 12 months
Comparing the number of SCI patients with any relevant side effects observed and the measured outcome in each arm by follow up Magnetic Resonance Imaging (MRI) and clinical signs and symptoms using ASIA scoring system..
4 secondary outcomes
Investigating the number of side effects in SCI patients receiving autologous BM-MSC.
Time frame: 12 months
Investigating the effectiveness of autologous BM-MSC in treating SCI patients.
Time frame: 12 months
Investigating the number of side effects in SCI patients receiving autologous AT-MSC.
Time frame: 12 months
Investigating the effectiveness of autologous AT-MSC in treating SCI patients.
Time frame: 12 months
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 24 Sep 2019.
- Cell Therapy Center WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
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.
Abdalla Awidi, MD study chair
University of Jordan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous Mesenchymal Stem Cells 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 4 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: finished, as of the sponsor's last update on 24 Sep 2019. 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 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 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?
Comparing the number of side effects and the improvement on ASIA Impairment score between SCI patients receiving autologous AT-MSC vs BM-MSC. (time frame: 12 months). 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 24 Sep 2019.