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Current Clinical Trials Criteria

If you would like to be considered for these or future Miami Project trials or studies, please see our Register for a Research Program section, send us a message, or call The Miami Project Education Office at 305-243-7108.

THE SAFETY AND EFFICACY OF AUTOLOGOUS HUMAN SCHWANN CELL (ahSC) AUGMENTATION OF NERVE AUTOGRAFTS AFTER SEVERE PERIPHERAL NERVE INJURY

Population

Peripheral Nerve Injury

 

Purpose

The purpose of this study is to assess the safety of autologous human Schwann cell (ahSC) augmentation of nerve autograft repair in participants with severe peripheral nerve injury (PNI). For humans with acute severe PNI, the hypothesis is that augmentation of nerve autograft repair with ahSCs can potentially enhance axonal regeneration and myelin repair and thus improve functional recovery.

 

Criteria

Inclusion Criteria

 

  • 18 to 65 years old
  • Severe sciatic nerve injury, brachial plexus injury, and/or major injury of the arm or leg with nerve loss within the previous year

 

Exclusion Criteria

 

  • Unable to safely have an MRI
  • Injury to legs that prevents the study doctor from being able to remove part of the sural nerve if needed
  • Severe nerve injury with a gap length greater than 10 mm
  • History of radiation or cancer in the area of your nerve injury, which includes primary tumors of the nerve
  • Currently pregnant or test positive for pregnancy upon enrollment
  • Disease that the study doctor believes will interfere with participant’s safety or compliance in relation to the study procedures
  • History of active substance abuse
  • Allergy to gentamicin
  • Positive for HIV or Hepatitis B or C virus

 

Study Start Date

September 24, 2019

 

Estimated Completion Date

September 1, 2029

 

Status

Enrolling

 

Principal Investigator/Contact

Principal Investigator: Allan D. Levi, M.D., Ph.D. / Katie Gant, Ph.D.

 

SYSTEMIC HYPOTHERMIA IN ACUTE CERVICAL SPINAL CORD INJURY

Population

Spinal Cord Injury – Acute

 

Purpose

The purpose of the proposed clinical trial is to demonstrate the safety and efficacy of intravascular hypothermia as part of the early hospital management and treatment for acute cervical SCI. Each year in the US, there are over 11,000 new cases of para- and quadriplegia and 100,000 new cases of partial but permanent neurological losses due to acute SCI. Thus the potential for clinical hypothermia following SCI to improve neurological outcome has significant value. Many patients suffering SCI become permanently dependent on caretakers and become a financial liability to both the family and society. Hypothermia has the potential to improve outcome so that more patients suffering SCI can regain independent motor and sensory function and remain economically productive members of society. The use of modest hypothermia through intravascular cooling may ultimately lead to better care of the patient with acute SCI and may also have more widespread uses in patients presenting with stroke or cardiac arrest. In the long-term, this research may lend support to the use of hypothermia that could in turn save money for the patients, hospitals, the government and society as a whole.

 

Criteria

Inclusion Criteria

 

  • 18 – 70 years of age
  • AIS Grade A – C
  • Glasgow Coma Scale ≥14
  • Able to start hypothermia treatment within 24 hours of injury
  • Non-penetrating injury. Patients urgently taken to the operating room for surgical reduction may also be included.

Exclusion Criteria

 

  • Age > 70 years
  • AIS Grade D
  • Hyperthermia on admission (>38.5ºC)
  • Severe systemic injury
  • Severe bleeding
  • Pregnancy
  • Coagulopathy
  • Thrombocytopenia
  • Known prior severe cardiac history
  • Blood dyscrasia
  • Pancreatitis
  • Reynaud’s syndrome
  • Cord transection

Study Start Date

August 4, 2017

 

Estimated Completion Date

March 2020

 

Status

Enrolling

 

Principal Investigator/Contact

Principal Investigator: Allan D. Levi, M.D., Ph.D.

 

SAFETY OF AUTOLOGOUS HUMAN SCHWANN CELLS (ahSC) IN SUBJECTS WITH SUBACUTE SCI

Population

Acute SCI

 

Purpose

The purpose of this study is to assess the safety of autologous human Schwann cells (ahSC) transplantation in subjects with subacute SCI.

For humans with subacute SCI, we hypothesize that axons might show improved function if myelin repair is induced with the implantation of ahSC. In addition spinal cord cavitation may be reduced, and neural sprouting and plasticity may be enhanced via neurotrophic effects.

 

Criteria

Persons with traumatic SCI that occurred within the previous 30 days, Between the ages of 18 and 60 at last birthday, SCI at a thoracic level between T3-T11 as defined by MRI and the most caudal level of intact motor and sensory function on the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), Acute SCI with ISNCSCI grade A impairment at time of enrollment.

 

Study Start Date

November 30, 2012

 

Study Completion Date

August 2016

 

Status

Completed – View Results

 

Principal Investigator/Contact

Study Director:              W. Dalton Dietrich, Ph.D.

Principal Investigator:    Allan D. Levi, M.D., Ph.D.

Principal Investigator:    James Guest, M.D., Ph.D.

 

SPINAL CORD INJURY REGISTRY - NACTN

Population

Acute SCI

 

Summary

The Miami Project and UM Department of Neurological Surgery are part of the North American Clinical Trials Network (NACTN). NACTN is a network of institutions that is developing the infrastructure, methods, and skilled personnel needed to conduct trials for SCI. Presently, the collaborative centers are collecting natural history data from newly injured people to determine the medical and rehabilitative outcomes and complications that occur in people receiving standard of care. Participants are evaluated for one year post-injury. The Miami Project has already enrolled more than 35 people to this registry. This information will help determine the design of SCI clinical trials because we will better understand complications that are risky for interventions at specific times post-injury and what degree of spontaneous recovery would be considered normal for different types of injuries.

 

Purpose

The NACTN Spinal Cord Injury Registry is a network of clinical centers collecting de-identified data from patients admitted through the Emergency Department of a NACTN center at the time of injury with an initial (first time) spinal cord injury (SCI). Information will be collected on the natural history of SCI and course of treatment through the first 12 months from the date of injury or long as medically indicated. Data collected includes imaging information from CT or MRI scans, neurological and general medical outcome and rehabilitation evaluation. No intervention is given other than standard of care for spinal cord injury, intensive monitoring and frequent follow up care.

 

Criteria

Any patient male or female > or equal to 18 years of age with first time spinal cord injury caused by trauma and has neurological deficit with paralysis (weakness) or loss of sensation (touch), Has not received prior medical of surgical care for this injury at an intermediate hospital, Must give informed consent.

 

Study Start Date

July 2005

 

Estimated Completion Date

July 2028

 

Status

Enrolling

 

Principal Investigator/Contact

Principal Investigator: James D. Guest, M.D., Ph.D. / George Jimsheleishvihi

 

RILUZOLE IN SPINAL CORD INJURY STUDY

Population

Acute SCI

 

Purpose

The aim of this study is to evaluate efficacy and safety of riluzole in the treatment of patients with acute SCI. The primary objective is to evaluate the superiority of riluzole, at a dose of 2 x 100 mg the first 24 hours followed by 2 x 50 mg for the following 13 days after injury, as compared to placebo, in change between 180 days and baseline in motor outcomes as measured by International Standards for Neurological Classification of Spinal Cord Injury Examination (ISNCSCI) Motor Score, in patients with acute traumatic SCI, presenting to the hospital less than 12 hours after injury. Secondary objectives are to evaluate the effects of riluzole on overall neurologic recovery, sensory recovery, functional outcomes, quality of life outcomes, health utilities, mortality, and adverse events. The working hypothesis is that the riluzole treated subjects will experience superior motor, sensory, functional, and quality of life outcomes as compared to those receiving placebo, with an acceptable safety profile.

 

Criteria

Age between 18 and 75 years inclusive, Able to cooperate in the completion of a standardized neurological examination by ISNCSCI standards (includes patients who are on a ventilator), Willing and able to comply with the study protocol.

 

Signed Informed Consent Document (ICD) by patient, legal representative or witness, Able to receive the Investigational Drug within 12 hours of injury, ISNCSCI Impairment Scale Grade “A,” “B” or “C” based upon first ISNCSCI evaluation after arrival to the hospital, Neurological Level of Injury between C4-C8 based upon first ISNCSCI evaluation after arrival to the hospital, Women of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test or a negative urine pregnancy test.

 

Study Start Date

October 2013

 

Estimated Completion Date

May 2025

 

Status

Enrolling

 

Principal Investigator/Contact

Principal Investigator: James D. Guest, M.D., Ph.D. / George Jimsheleishvili

 

BRAIN MACHINE INTERFACE (BMI) IN SUBJECTS LIVING WITH QUADRIPLEGIA

Population

Chronic SCI

 

Purpose

In this study, investigators will show proof-of-concept that brain signals can be used in real-time, closed-loop mode to trigger stimulation for hand function. Subjects will undergo surgery to implant a unilateral subdural strip electrode (Resume II, Model 3587A) over the motor cortex. These electrodes implanted in the brain will enable bioelectrical data recording (sensing) from the brain to the implanted Activa PC+S. The cortical sensing data will be either processed in the Activa PC+S; or off-loaded via the Nexus D communication device (Medtronic) to a computer.

 

 

Criteria

AIS Grades A & B, Level of Injury C5 or C6, Local Community dwelling, Stable chronic injury, Stable health status and upper extremities, Completion of Clinical Protocol 01

 

Study Start Date

November 2015

 

Estimated Completion Date

December 2020

 

Status

Enrolling in 2020

 

Principal Investigator/Contact

Principal Investigator: Jonathan R. Jagid, M.D.

 

TRANSFORMING RESEARCH AND CLINICAL KNOWLEDGE IN TRAUMATIC BRAIN INJURY (TRACK-TBI)

Population

Acute TBI Mild – Severe

 

Purpose

The overall goal of Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study is to determine the relationships among the clinical, neuroimaging, cognitive, genetic and proteomic biomarker characteristics for the entire spectrum of TBI from concussion to coma. TRACK-TBI will validate biomarkers and outcome measures for clinical trials, advance diagnostic and prognostic models for TBI and improve clinical trial design. The Investigators are enrolling patients within 24 hours of injury who present to a TRACK-TBI site with a brain injury that meets ACRM criteria and receives a clinically indicated head CT.

 

Criteria

Age 18-100 (some sites also enrolling pediatric patients), Documented/verified TBI by ACRM Criteria, Injury occurred within 24 hours of ED arrival, Acute brain CT as part of clinical care, Visual acuity and hearing adequate for outcomes testing, Fluency in English (some sites also enrolling Spanish speakers).

 

Study Start Date

April 21, 2014

 

Last Verified

November 2019

 

Status

Enrolling

 

Principal Investigator/Contact

Principal Investigator: Gillian A. Hotz, Ph.D.

 

 

If you would like to be considered for these or future Miami Project trials or studies, please register now!