Spinal Cord InjuryPhase 1/2NCT02237547
Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury
A Phase 1/2 study testing Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells in people with Spinal Cord Injury, run by Translational Biosciences at 1 site in Panama.
Trial summary
Human Umbilical Cord-derived Mesenchymal Stem Cells (UC-MSC) and Bone Marrow Mononuclear Cells (BMMC) from the patient injected into the spinal fluid intrathecally and injected intravenously (IV) is a safe and therapeutic procedure for spinal cord injury (SCI) patients. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 sitePanama
- Study dates
- Sep 2014to Oct 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women between age 18 and 50
- Paraplegics and quadriplegics with complete or incomplete spinal cord injuries.
- Willingness to undergo bone marrow derived autologous cell therapy.
- Ability and willingness to make regular visits to hospital and follow ups during the protocol procedure and comply with all medical instructions
- Traumatic Injury of spinal cord with complete or partial damage by Magnetic Resonance Imaging (MRI) and injury level below C4
- ASIA impairment scale from A - C
- Must have proof of health insurance in country of residence.
- Signed informed consent
Who cannot join
- Pre- existing or current systemic disease such as lung, liver (exception: history of uncomplicated hepatitis A), gastrointestinal, cardiac, Human Immunodeficiency Virus (HIV)
- History of life threatening allergic- or immune-mediated reaction
- Hemodynamic instability
- Peripheral muscular dystrophy
- Lactating or pregnant woman
- Women capable of childbearing unwilling to use multiple forms of contraception
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- Alcohol drug abuse /dependence
- Positive test result for hepatitis A and Hepatitis B OR C
- Major-traumatic brain injury and psychiatric illness
- Open injuries
- Active infectious diseases
- Life expectancy of less than one year due to terminal condition
- Neurodegenerative diseases
- Primary hematologic diseases
- Any of the following medications that cannot be discontinued one week prior to the first stem cell administration and throughout the course of treatment. (1 week before visit 2 through one week after visit 12)
- Antibiotics
- Antifungals
- Antivirals
- Blood thinners (to avoid bleeding risk during bone marrow aspiration and IT procedures)
- High doses of Vitamin D or fish oils (since these might prolong bleeding times)
- Bone reflecting increased risk for spinal puncture
- Hepatic dysfunction
- Other medical complications that contraindicate surgery, including major respiratory complications
- Participation in another clinical trial
- Coagulopathies
- Uncorrected coagulopathy during the baseline period defined as: International Normalized Ratio (INR) > 1.4; Partial Thromboplastin Time (PTT) > 35 sec; Platelet Count (PLT) < 100,000.
- Pre-injury history of seizure disorder and/or neurological impairment where participation in age-appropriate pain rating scales would not be practical or possible
- Subject does not sign informed consent form
Trial locations and contacts
1 site in 1 country.
About this study
Human Umbilical Cord-derived Mesenchymal Stem Cells (UC-MSC) and Bone Marrow Mononuclear Cells (BMMC) from the patient injected into the spinal fluid intrathecally and injected intravenously (IV) is a safe and therapeutic procedure for spinal cord injury (SCI) patients.
Read the detailed description
The proposed study will assess primary safety and secondary efficacy endpoints of autologous bone marrow mononuclear cells and allogeneic human umbilical cord-derived mesenchymal stem cells administered to 20 male and female subjects between ages of 18-50 with spinal cord injury. These cells will be administered intrathecally and intravenously multiple times over the course of one month.
The primary objective is freedom from treatment-associated adverse events at 3 and 12 months post-treatment. Secondary objective will be efficacy at baseline, 3 months and 12 months and will be quantified based on the following: American Spinal Cord Injury Association (ASIA) classification and the Frankel Scale.
- Conditions
- Spinal Cord Injury
- Being tested
- Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells
- Keywords
- spinal cord injury, mesenchymal, bone marrow, mononuclear cells, stem cells, umbilical cord
- 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.
Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cellsBiological
| Study group | Role | What they receive |
|---|---|---|
| IV and IT UC-MSC and BMMC | Experimental | Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells Receives: Biological: Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
12 and 52 weeks after final treatment
Measured: 12 weeks, 52 weeks
Secondary outcomes (2)
Number of subjects with a change in American Spinal Injury Association (ASIA) score from baseline
12 and 52 weeks after final treatment
Measured: 12 weeks, 52 weeks
Number of subjects with a change in Frankel Scale score from baseline
12 and 52 weeks from final treatment
Measured: 12 weeks, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2019 (estimated)
- Study completionOct 2019 (estimated)
Why it stopped: No enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nelson Novarro, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237547
- Sponsor's protocol ID
- CNEI-2014-TBS-UCMSC-SCI001
- Status last verified
- Aug 2017
- First submitted
- 9 Sep 2014
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02237547
- Acronym / sponsor ID
- CNEI-2014-TBS-UCMSC-SCI001
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury, mesenchymal, bone marrow, mononuclear cells, stem cells, umbilical cord
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Translational BiosciencesIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 11 Sep 2014 (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.
Human Umbilical Cord-derived Mesenchymal Stem Cells (UC-MSC) and Bone Marrow Mononuclear Cells (BMMC) from the patient injected into the spinal fluid intrathecally and injected intravenously (IV) is a safe and therapeutic procedure for spinal cord injury (SCI) patients.
Detailed description
The proposed study will assess primary safety and secondary efficacy endpoints of autologous bone marrow mononuclear cells and allogeneic human umbilical cord-derived mesenchymal stem cells administered to 20 male and female subjects between ages of 18-50 with spinal cord injury. These cells will be administered intrathecally and intravenously multiple times over the course of one month.
The primary objective is freedom from treatment-associated adverse events at 3 and 12 months post-treatment. Secondary objective will be efficacy at baseline, 3 months and 12 months and will be quantified based on the following: American Spinal Cord Injury Association (ASIA) classification and the Frankel Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IV and IT UC-MSC and BMMC | Experimental | Biological: Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cellsIntravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Men and women between age 18 and 50
- Paraplegics and quadriplegics with complete or incomplete spinal cord injuries.
- Willingness to undergo bone marrow derived autologous cell therapy.
- Ability and willingness to make regular visits to hospital and follow ups during the protocol procedure and comply with all medical instructions
- Traumatic Injury of spinal cord with complete or partial damage by Magnetic Resonance Imaging (MRI) and injury level below C4
Key exclusion criteria (28 listed)
- Pre- existing or current systemic disease such as lung, liver (exception: history of uncomplicated hepatitis A), gastrointestinal, cardiac, Human Immunodeficiency Virus (HIV)
- History of life threatening allergic- or immune-mediated reaction
- Hemodynamic instability
- Peripheral muscular dystrophy
- Lactating or pregnant woman
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 |
|---|---|---|
| Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells | Biological | IV and IT UC-MSC and BMMC |
Primary outcome
Number of patients with adverse events
Time frame: 12 weeks, 52 weeks
12 and 52 weeks after final treatment
2 secondary outcomes
Number of subjects with a change in American Spinal Injury Association (ASIA) score from baseline
Time frame: 12 weeks, 52 weeks
Number of subjects with a change in Frankel Scale score from baseline
Time frame: 12 weeks, 52 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
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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.
Nelson Novarro, MD principal investigator
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 Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells in people with Spinal Cord Injury, run by Translational Biosciences at 1 site in Panama.
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 8 inclusion and 28 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: withdrawn, as of the sponsor's last update on 10 Aug 2017. 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 Panama. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of patients with adverse events (time frame: 12 weeks, 52 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 10 Aug 2017.