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

NCT02416492 | Completed Phase 2 Results DMC

• 1 other identifier: TBI-01
• Study Type: interventional
• Target: 63
• Locations: 3 countries
• Sites: 36

Brief 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. 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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (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).

  24 weeks

Secondary Outcomes (5)

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

  24 weeks

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

  24 weeks

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

  24 weeks

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

  24 weeks

• 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

  24 weeks

Study Arms (2)

SB623 Cells

EXPERIMENTAL

SB623 Cells: 2.5, 5 or 10 million cells

Biological: SB623 cells

Sham Surgery

SHAM COMPARATOR

Control Sham Surgery

Procedure: Sham Control

Interventions

SB623 cells BIOLOGICAL

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

SB623 Cells

Sham Control PROCEDURE

Sham Surgery

Sham Surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• SanBio, Inc.: lead

Study Sites (36)

UCLA Medical Center (Surgical/Assessment)

Los Angeles, California, 90095, United States

Location

Ronald Reagan UCLA Medical Denter

Los Angeles, California, United States

Location

The Research Center of Southern California, LLC (Assessment)

Oceanside, California, 92056, United States

Location

University of California, Irvine (Assessment/Surgical)

Orange, California, 92868, United States

Location

Westview Clinical Research (Assessment)

Placentia, California, 92870, United States

Location

Providence Saint John's Health Center

Santa Monica, California, 90404, United States

Location

John Wayne Cancer Institute at Providence St. Johns Health Center

Santa Monica, California, United States

Location

Stanford Health Care (Surgical/Assessment)

Stanford, California, 94305, United States

Location

Craig Hospital

Englewood, Colorado, 80113, United States

Location

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

Stamford, Connecticut, 06905, United States

Location

SouthCoast Research Center

Miami, Florida, 33136, United States

Location

Midtown Neurology, PC (Assessment)

Atlanta, Georgia, 30312, United States

Location

Emory University Hospital (Surgical)

Atlanta, Georgia, 30322, United States

Location

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Shirley Ryan Ability Lab

Chicago, Illinois, United States

Location

NYU Langone Medical Center (Surgical/Assessment)

New York, New York, 10016, United States

Location

New York University Langone Medical Center

New York, New York, United States

Location

Burke Rehab Center (Assessment)

White Plains, New York, 10605, United States

Location

Ohio Health Research

Columbus, Ohio, 43214, United States

Location

Moss Rehab (Assessment)

Elkins Park, Pennsylvania, 19027, United States

Location

University of Pittsburgh Medical Center (Surgical/Assessment)

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, United States

Location

Medical University of South Carolina (Surgical)

Charleston, South Carolina, 29425, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

Mid-Columbia Research

Richland, Washington, 99352, United States

Location

Hokkaido University Hospital (Surgical/Assessment)

Sapporo, Hokkaido, 060-8648, Japan

Location

Yokohama City University Hospital (Surgical/Assessment)

Yokohama, Kanagawa, 236-0004, Japan

Location

Okayama University Hospital (Assessment/Surgical)

Okayama, Okayama-ken, 700-8655, Japan

Location

Osaka University Hospital (Assessment/Surgical)

Suita, Osaka, 565-0871, Japan

Location

University of Tokyo Hospital (Assessment/Surgical)

Bunkyo, Tokyo, 113-8655, Japan

Location

Hokkaido University Hospital

Hokkaido, Japan

Location

Okayama University Hospital

Okayama, Japan

Location

Osaka University Hospital

Osaka, Japan

Location

University of Tokyo Hospital

Tokyo, Japan

Location

Yokohama City University Hospital

Yokohama, Japan

Location

Clinical Hospital Feofaniia

Kiev, 03680, Ukraine

Location

Related Publications (3)

• 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.

  PMID: 39231380 DERIVED

• 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.

  PMID: 34402352 DERIVED

• 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.

  PMID: 33397772 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Bijan Nejadnik M.D.; Chief Medical Officer
• Organization: SanBio, Inc.

Bijan.Nejadnik@sanbio.com

650-625-2205

Study Officials

• Daniel C Lu, MD, PhD

  University of California, Los Angeles, Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: April 15, 2015
• Study Start: July 6, 2016
• Primary Completion: January 31, 2019
• Study Completion: March 5, 2019
• Last Updated: December 27, 2021
• Results First Posted: December 27, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (10); US (25); UA (1)