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Mesenchymal Stem Cell Therapy
Stem Cell Therapy for Spinal Cord Injury
Phase 2
Recruiting
Led By Mohamad Bydon, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
AIS grade A or B of SCI at the time of injury with or without subsequent improvement within 1 year of injury that has progressed to a higher AIS grade with a plateau in functional improvement
Be older than 18 years old
Must not have
History of receiving mesenchymal stem cell, gene or exosome therapy for any indications
Any contraindication to MRI scan according to MRI guidelines, or unwillingness to undergo MRI procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months post injection
Awards & highlights
Summary
This trial will investigate whether injecting stem cells derived from fat tissue into the spinal cord is safe and effective in treating spinal cord injury.
Who is the study for?
Adults aged 18+ with traumatic, non-penetrating spinal cord injuries (SCI) graded A or B at injury time, who've seen no significant improvement for a year. Participants must understand and commit to the study's requirements including home exercises and follow-ups. Women of childbearing age need a negative pregnancy test and must use contraception during the study.
What is being tested?
The trial is testing if one's own adipose-derived mesenchymal stem cells can safely improve SCI outcomes when injected into the spinal fluid, alongside standard occupational and physical therapy treatments.
What are the potential side effects?
Potential side effects may include reactions at injection site, infection risk due to stem cell harvest/injection procedures, immune system responses to stem cells, or discomfort from fat tissue harvesting for those providing their own stem cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My spinal cord injury was severe at first but improved within a year, though it has not gotten better since.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had treatments involving stem cells, gene therapy, or exosomes.
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I can have an MRI and am willing to undergo MRI procedures.
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I do not have any ongoing infectious diseases like TB, HIV, hepatitis, or syphilis.
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I have had an infection in my spine before.
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I currently have a skin infection near my spine.
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I have a history of blood disorders such as anemia or low platelet counts.
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I have a serious heart, brain, kidney, liver, or hormone-related condition.
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I have a fever over 100.4 F or am experiencing confusion.
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I have been diagnosed with schizophrenia or bipolar disorder.
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I am currently taking riluzole for ALS.
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I am on long-term medication that weakens my immune system.
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My spinal cord injury is not classified as complete (A) or nearly complete (B).
Select...
My spinal cord injury was not caused by a physical injury.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months post injection
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months post injection
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
•Change in sensory and motor function following completion of treatment as measured by the American Spinal Injury Association (ASIA) Impairment Scale (AIS)
Secondary study objectives
Change in sensory and motor function following completion of treatment as measured by Somatosensory Evoked Potentials (SSEPs)
Correlation of adverse events to study drug
Incidence of abnormal CSF composition
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment Group 1: AD-MSC InjectionExperimental Treatment1 Intervention
Patients will receive a single dose of autologous, adipose derived mesenchymal stem cells one time. The cells are isolated from patient's adipose tissue and expanded for intrathecal delivery.
Group II: Treatment Group 2: Best Medical ManagementActive Control2 Interventions
Patients will be observed over six months while attending physical and occupational therapy. After six months, patients will receive a single dose of autologous, adipose derived mesenchymal stem cells one time. The cells are isolated from patient's adipose tissue and expanded for intrathecal delivery.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,298 Previous Clinical Trials
3,958,405 Total Patients Enrolled
2 Trials studying Paralysis
122 Patients Enrolled for Paralysis
Mohamad Bydon, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
10 Total Patients Enrolled
1 Trials studying Paralysis
10 Patients Enrolled for Paralysis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have taken medication for rheumatic disease in the last 3 months.I have had treatments involving stem cells, gene therapy, or exosomes.I can have an MRI and am willing to undergo MRI procedures.I do not have any ongoing infectious diseases like TB, HIV, hepatitis, or syphilis.I have had an infection in my spine before.I currently have a skin infection near my spine.I have a history of blood disorders such as anemia or low platelet counts.I had a minor infection in my spine within the last 6 months.I am not pregnant, can use birth control, and am of childbearing age.My spinal cord injury was severe at first but improved within a year, though it has not gotten better since.I have a serious heart, brain, kidney, liver, or hormone-related condition.You have a history of or currently use alcohol, drugs, or medical marijuana for non-medical reasons within the last 30 days.I have a fever over 100.4 F or am experiencing confusion.If a woman becomes pregnant during the study, she will be closely watched to make sure both she and the baby are healthy. Any serious issues related to the pregnancy will be noted.My condition improved significantly after fat tissue was taken and before it was injected back.I have had cancer before, but only skin cancer without serious spread in the last 3 years.You have been diagnosed with depression using the Beck Depression Inventory Assessment before starting the trial.I have been diagnosed with schizophrenia or bipolar disorder.I am not pregnant, will use birth control, and understand the pregnancy monitoring requirements.I am currently taking riluzole for ALS.I am on long-term medication that weakens my immune system.I fully understand the home exercise program given by my therapists.I am 18 years old or older.Your spinal cord injury must be caused by a traumatic, non-penetrating event, and not from a degenerative condition.My spinal cord injury is not classified as complete (A) or nearly complete (B).My spinal cord injury was not caused by a physical injury.I understand and agree to follow the study's requirements, including all tests and visits.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group 1: AD-MSC Injection
- Group 2: Treatment Group 2: Best Medical Management
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Paralysis Patient Testimony for trial: Trial Name: NCT04520373 — Phase 2
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