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Traumatic Brain InjuryPhase 2STEMTRANCT02416492

A Study of Modified Stem Cells in Traumatic Brain Injury (TBI)

A Phase 2 study testing SB623 cells in people with Traumatic Brain Injury, run by SanBio, Inc. at 36 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary purpose of the clinical study is to evaluate the clinical efficacy of intracranial administration of SB623 cells on patients with chronic motor deficit from Traumatic Brain Injury. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Traumatic Brain Injury
What is being tested?
SB623 cells
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
63 participants
Where
36 sitesin 3 countries
Study dates
6 Jul 2016to 5 Mar 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented history of TBI, with correlated MRI or CT
  • At least 12 months post-TBI
  • Focal cerebral injury able to be identified on MRI (+/- concomitant diffuse axonal injury)
  • 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 Motricity Index 10-81 (UE Scale) and/or 10-78 (LE Scale)
Show all 9Show fewer
  • Able and willing to undergo computed tomography (CT) and magnetic resonance imaging (MRI)
  • Subjects must be willing to participate in study related exercises to the extent possible
  • Able to undergo all planned neurological assessments

Who cannot join

  • History or presence of any other major neurological disease
  • Any seizures in the prior 3 months
  • The presence of contracture at any joints that would interfere with interpretation of any of the neurological assessments (e.g. contracture preventing the detection of any increase in the range of motion or ability to perform a task)
  • Other neurologic, neuromuscular or orthopedic disease that limits motor function
  • Clincially significant finding on MRI of brain not related to TBI
  • Known presence of any malignancy except squamous or basal cell carcinoma of the skin
Show all 19Show fewer
  • 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 (without bone flap replacement) or other contraindication to stereotactic surgery
  • Participation in any other investigational trial within 4 weeks of initial screening or within 7 weeks of study entry
  • Botulinum toxin injection, phenol injection, intrathecal baclofen, or any other interventional treatments for spasticity (except bracing and splinting) 16 weeks priot to the Baseline visit.
  • 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

Trial locations and contacts

36 sites in 3 countries.

36 sites in 3 countries

United States25 sites

  • Midtown Neurology, PC (Assessment)

    Atlanta, Georgia, 30312

  • Emory University Hospital (Surgical)

    Atlanta, Georgia, 30322

  • Medical University of South Carolina (Surgical)

    Charleston, South Carolina, 29425

  • Rehabilitation Institute of Chicago

    Chicago, Illinois, 60611

  • Shirley Ryan Ability Lab

    Chicago, Illinois

  • Ohio Health Research

    Columbus, Ohio, 43214

  • Moss Rehab (Assessment)

    Elkins Park, Pennsylvania, 19027

  • Craig Hospital

    Englewood, Colorado, 80113

  • UCLA Medical Center (Surgical/Assessment)

    Los Angeles, California, 90095

  • Ronald Reagan UCLA Medical Denter

    Los Angeles, California

  • SouthCoast Research Center

    Miami, Florida, 33136

  • NYU Langone Medical Center (Surgical/Assessment)

    New York, New York, 10016

  • New York University Langone Medical Center

    New York, New York

  • The Research Center of Southern California, LLC (Assessment)

    Oceanside, California, 92056

  • University of California, Irvine (Assessment/Surgical)

    Orange, California, 92868

  • University of Pittsburgh Medical Center (Surgical/Assessment)

    Pittsburgh, Pennsylvania, 15213

  • University of Pittsburgh School of Medicine

    Pittsburgh, Pennsylvania

  • Westview Clinical Research (Assessment)

    Placentia, California, 92870

  • Mid-Columbia Research

    Richland, Washington, 99352

  • Virginia Commonwealth University

    Richmond, Virginia, 23219

  • Providence Saint John's Health Center

    Santa Monica, California, 90404

  • John Wayne Cancer Institute at Providence St. Johns Health Center

    Santa Monica, California

  • Ki Health Partners, LLC dba New England Institute for Clinical Research (Assessment)

    Stamford, Connecticut, 06905

  • Stanford Health Care (Surgical/Assessment)

    Stanford, California, 94305

  • Burke Rehab Center (Assessment)

    White Plains, New York, 10605

Other trials in United States

Japan10 sites

  • University of Tokyo Hospital (Assessment/Surgical)

    Bunkyo, Tokyo, 113-8655

  • Hokkaido University Hospital

    Hokkaido

  • Okayama University Hospital (Assessment/Surgical)

    Okayama, Okayama-ken, 700-8655

  • Okayama University Hospital

    Okayama

  • Osaka University Hospital

    Osaka

  • Hokkaido University Hospital (Surgical/Assessment)

    Sapporo, Hokkaido, 060-8648

  • Osaka University Hospital (Assessment/Surgical)

    Suita, Osaka, 565-0871

  • University of Tokyo Hospital

    Tokyo

  • Yokohama City University Hospital (Surgical/Assessment)

    Yokohama, Kanagawa, 236-0004

  • Yokohama City University Hospital

    Yokohama

Other trials in Japan

Ukraine1 site

  • Clinical Hospital Feofaniia

    Kiev, 03680

Other trials in Ukraine

About this study

Official title: A Double-Blind, Controlled Phase 2 Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Traumatic Brain Injury (TBI)

The primary purpose of the clinical study is to evaluate the clinical efficacy of intracranial administration of SB623 cells on patients with chronic motor deficit from Traumatic Brain Injury. A secondary purpose of the study is 1) to evaluate the effect of intracranial administration of SB623 cells on disability parameters and 2) to evaluate the safety and tolerability of intracranial administration of SB623 cells. Patients with stable, chronic motor deficits secondary to focal traumatic brain injury must be 12 months post TBI.

Read the detailed description

This study was a multicenter, randomized (3:1) double-blind, active and sham-surgery controlled study to evaluate the safety, tolerability, and efficacy of stereotactic intracranial injection of SB623 cells in patients with fixed motor deficits from TBI. The study was conducted at approximately 22 sites across the United States, Ukraine, and Japan.

Two groups, Group 1 and Group 2, received investigational product SB623 and sham surgery, respectively, in a 3:1 randomization scheme. Group 1 was further randomized in a 1:1:1 ratio to receive either 2.5 million, 5 million, or 10 million SB623 cells. Randomization was performed via an interactive web response system (IWRS).

Being tested
SB623 cells, Sham Control
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SB623 cellsBiological

    SB623 cells will be implanted in the peri-infarct area using stereotactic surgery.

  • Sham ControlProcedure or surgery

    Sham Surgery

Study groups in NCT02416492
Study groupRoleWhat they receive
SB623 CellsExperimentalSB623 Cells: 2.5, 5 or 10 million cells
Receives: Biological: SB623 cells
Sham SurgerySham comparatorControl Sham Surgery
Receives: Procedure: Sham Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Fugl-Meyer Motor Scale (FMMS) Score at Week 24 Among All Patients

    The FMMS motor component consists of the 33-item upper extremity subscale (UE-FMMS) and the 17-item lower extremity subscale (LE-FMMS). Items were scored on a 3-point ordinal scale: 0= cannot perform; 1= partial motion; 2= full motion Individual items were then summed to determine scores for the 2 subscale scores, as well as a motor total score (total of all item scores including the 2 subscales UE-FMMS and LE-FMMS). As a result, the UE-FMMS subscale score ranged from 0 to 66 and the LE-FMMS subscale score ranged from 0 to 34. The FMMS motor total score ranged from 0 (hemiplegia) to a maximum of 100 points (normal motor performance).

    Measured: 24 weeks

Secondary outcomes (5)

  1. Change From Baseline in Disability Rating Scale Score at Week 24 Among All Patients

    DRS is an observer rated, 30-point ordinal scale that evaluates eight areas of functioning in four categories:

    1. Consciousness (eye opening, verbal response, motor response)
    2. Cognitive ability (feeding, toileting, grooming)
    3. Dependence on others
    4. Employability

    Each area of functioning was rated on a scale of 0 to either 3 or 5. The maximum score is 29 (extreme vegetative state) and the minimum score is 0 (person without disability).

    Measured: 24 weeks

  2. Change From Baseline in ARAT Total Score at Week 24 Among Upper Extremity Deficit Patients

    The ARAT total score is the sum of the scores from 19 tests spread across four subscales: grasp, grip, pinch, and gross movement. Each test is scored on an ordinal 4-point scale with 0= non movement, 1 = the movement task is partially performed, 2 = the movement task is completed but takes abnormally long, and 3 = the movement is performed normally. Summation of a 0-3 score in each item yields a total score between 0 and 57.

    Measured: 24 weeks

  3. Change From Baseline in Gait Velocity (10 Meter Walk Time in Seconds) at Week 24 Among Lower Extremity Deficit Patients

    Gait Velocity was measured on a standard 10 meter walk.

    Measured: 24 weeks

  4. Change From Baseline in NeuroQOL T-scores at Week 24 of NeuroQOL Domains

    Two NeuroQoL short form assessments were used (upper extremity function and lower extremity function); each has 8 items with 5 possible scores (e.g. 1= not at all, 2=a little bit, 3= somewhat, 4=quite a bit, 5=very much) or frequency ("never"to "always"); Raw scores are converted to T-scores based on a consistent metric (i.e., the T distribution) and data from the US general population. The theoretical range in scale for Upper extremity T-score and Lower extremity T-score are 12.8 to 53.8 and 16.5 to 58.6 respectively. When interpreting these T-scores, higher scores correspond to higher levels of functioning whereas lower scores correspond to lower levels of functioning.

    Measured: 24 weeks

  5. Global Rating of Perceived Change: The Percentage of Subjects Scoring Either 6 or 7 on the Global Rating of Perceived Change by Both Subject and Physician

    The proportions of SB623 treated subjects (pooling all SB623 doses) scoring either 7 (much better) or 6 (a little better, meaningful) on the Global Rating of Perceived Change (from Baseline) - Subject at Week 24 and on the Global Rating of Perceived Change (from Baseline) - Clinician at Week 24 was compared to the corresponding proportions of sham surgery control subjects using logistic regression models with adjustment for the baseline Fugl-Meyer Motor Scale score and the GOS-E score at screening as continuous covariates. The following 7-point Likert scale was used

    • Score 7 = Much better
    • Score 6 = A little better, meaningful
    • Score 5 = A little better, not meaningful
    • Score 4 = About the same
    • Score 3 = A little worse, not meaningful
    • Score 2 = A little worse, meaningful
    • Score 1 = Much worse

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2015 (estimated)
  2. Study start6 Jul 2016
  3. Primary completion31 Jan 2019
  4. Study completion5 Mar 2019

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02416492
Sponsor's protocol ID
TBI-01
Acronym
STEMTRA
Status last verified
Nov 2021
First submitted
6 Apr 2015
Last updated
27 Dec 2021
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Okonkwo DO, McAllister P, Achrol AS, Karasawa Y, Kawabori M, Cramer SC, Lai A, Kesari S, Frishberg BM, Groysman LI, Kim AS, Schwartz NE, Chen JW, Imai H, Yasuhara T, Chida D, Nejadnik B, Bates D, Stonehouse AH, Richardson RM, Steinberg GK, Poggio EC, Weintraub AH. Mesenchymal Stromal Cell Implants for Chronic Motor Deficits After Traumatic Brain Injury: Post Hoc Analysis of a Randomized Trial. Neurology. 2024 Oct 8;103(7):e209797. doi: 10.1212/WNL.0000000000209797. Epub 2024 Sep 4.

    PubMed 39231380

  • McCrea MA, Cramer SC, Okonkwo DO, Mattke S, Paadre S, Bates D, Nejadnik B, Giacino JT. Determining minimally clinically important differences for outcome measures in patients with chronic motor deficits secondary to traumatic brain injury. Expert Rev Neurother. 2021 Sep;21(9):1051-1058. doi: 10.1080/14737175.2021.1968299. Epub 2021 Aug 26.

    PubMed 34402352

  • Kawabori M, Weintraub AH, Imai H, Zinkevych I, McAllister P, Steinberg GK, Frishberg BM, Yasuhara T, Chen JW, Cramer SC, Achrol AS, Schwartz NE, Suenaga J, Lu DC, Semeniv I, Nakamura H, Kondziolka D, Chida D, Kaneko T, Karasawa Y, Paadre S, Nejadnik B, Bates D, Stonehouse AH, Richardson RM, Okonkwo DO. Cell Therapy for Chronic TBI: Interim Analysis of the Randomized Controlled STEMTRA Trial. Neurology. 2021 Feb 22;96(8):e1202-e1214. doi: 10.1212/WNL.0000000000011450.

    PubMed 33397772

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SB623 cells in people with Traumatic Brain Injury, run by SanBio, Inc. at 36 sites in 3 countries.

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 9 inclusion and 19 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: finished, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, Japan, Ukraine. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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?

Yes. Results are posted in the registry (first posted 27 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Fugl-Meyer Motor Scale (FMMS) Score at Week 24 Among All Patients (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02416492, which also lists 3 linked publications.

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 27 Dec 2021.

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