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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

No Placebo-Only Group

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 below

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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:

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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).

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months post injection for reporting.

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 14Eligibility criteria met