Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02416492 : A Study of Modified Stem Cells in Traumatic Brain Injury (TBI)
PhasePhase 2
AgesMin: 18 Years Max: 75 Years
Eligibility
Inclusion Criteria:

- Documented history of TBI, with correlated MRI or CT

- Between 12 and 36 months post-TBI

- Focal cerebral injury able to be identified on MRI

- Neurological motor deficit substantially due to focal cerebral injury observed on MRI

- GOS-E score of 3-6 (i.e. moderate or severe disability)

- Require both Motricity Index 30-75 (UE Scale) and 27-74 (LE Scale)

- Able and willing to undergo computed tomography (CT) and magnetic resonance imaging
(MRI)

- Subjects must have had physical therapy prior to entry and be willing to continue to
the extent possible

- Able to undergo all planned neurological assessments

Exclusion Criteria:

- History or presence of any other major neurological disease

- Any seizures in the prior 3 months

- More than 5 degrees of contracture at shoulder, elbow, wrist, fingers, hip, knee and
ankle

- Other neurologic, neuromuscular or orthopedic disease that limits motor function

- Known presence of any malignancy except squamous or basal cell carcinoma of the skin

- History of CNS malignancy

- Positive findings on tests for occult malignancy, unless a non-malignant etiology is
confirmed

- Uncontrolled systemic illness, including, but not limited to: hypertension (systolic
>150 mm Hg or diastolic >95 mm Hg); diabetes; renal, hepatic, or cardiac failure

- Uncontrolled major psychiatric illness, including depression symptoms (CESD-R Scale
of ?16)

- Unexplained abnormal preoperative test values (blood tests, electrocardiogram [ECG],
chest X-ray); x-ray evidence of infection; uncontrolled atrial fibrillation or
uncontrolled congestive heart failure

- Presence of craniectomy or other contraindication to stereotactic surgery

- Participation in any other investigational trial within 4 weeks of initial screening

- Botulinum toxin injection, phenol injection, intrathecal baclofen, or any other
interventional treatments for spasticity (except bracing and splinting) within the
previous 4 mos.

- Ongoing use of other non-traditional drugs

- Substance use disorder (per DSM-V criteria, including drug or alcohol)

- Contraindications to head CT or MRI

- Pregnant or lactating

- Female patients of childbearing potential unwilling to use an adequate birth control
method during the 12 months of the study
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02416492      |      Link to official Clinicaltrials.gov listing
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