This is a Phase 1 Clinical Safety Study intended to provide preliminary assessments of the safety, tolerability, and clinical alleviation of symptoms associated with Post Concussion Syndrome (PCS), also known as Chronic Concussive Syndrome (CCS).
The proposed study is a single-site, double-blinded, placebo-controlled study involving a single administration of either individual, autologous ATCell™ lines suspended in 5% dextrose lactated Ringer's solution or a vehicle (5% dextrose Lactated Ringer's solution) not containing cells. Each ATCell™ cell line will be created from cells grown from the stromal vascular fraction (SVF) of a participant's own adipose tissue collected by liposuction, and each treated participant will only receive their own cells. Within the treated group, 3 dosing levels will be explored: 50 million cells, 150 million cells, or 300 million cells, and a Placebo group which will receive 5% dextrose lactated Ringer's solution free of cells. Participant follow-ups will take place 1 day following the tissue harvest procedure and, 1 day, 1 week, 1 month, 3 months, and 6 months following ATCell™ treatment. Comprehensive participant's evaluations involving data collection will take place 1, 3, and 6 months following treatment. It has been proposed that in general, mild traumatic brain injuries (TBI) events need to be taken far more seriously, and that even mild TBI events can result in lasting negative consequences as evidenced by lower performances on neuropsychological assessments when compared with age-matched controls2. In fact, this condition may eventually lead to Alzheimer's Disease (AD) as well as Chronic Traumatic Encephalopathy (CTE), which, together may be termed the AD-like dementias3, further underscoring the need for effective clinical intervention. Currently, no effective treatments are available for this condition aside from treatment of the symptoms, although some more comprehensive treatments have been proposed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
Each participant in this arm will receive a single dose of 50 million cultured adipose derived stem cells derived from their own adipose (fat) tissue via infusion therapy delivery over the course of one hour.
Each participant in this arm will receive a single dose of 150 million cultured adipose derived stem cells derived from their own adipose (fat) tissue via infusion therapy delivery over the course of one hour.
Each participant in this arm will receive a single dose of 300 million cultured adipose derived stem cells derived from their own adipose (fat) tissue via infusion therapy delivery over the course of one hour.
BioSolutions Clinical Research Center
La Mesa, California, United States
Health Status using the 36 item Short Form Health Survey (SF-36)
Completed by Participant as a part of physician visits at baseline, and 1, and 6 months following treatment . Scores of completed SF-36 will be numerically determined and compared to baseline. Changes against baseline will be represented numerically (positive or negative).The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Time frame: Baseline, 1 month and 6 months post treatment
Assessment of Visual Attention and Task Switching
Administered by study staff as a part of physician visits at baseline, and 1, and 6 months following treatment . Scores How long it takes the participant to connect a sequence of 25 consecutive targets in sequential order on a sheet of paper or computer screen to complete the two tests will be numerically determined (seconds) and compared to baseline. The goal of the test is for the subject to finish both parts as quickly as possible, with the time taken to complete the test being used as the primary performance metric If a person makes an error in the test, there's no change in the score other than that it makes their completion time longer since the person has to go back to correct the error, thus extending their time, shorter completion times indicate improved scores.
Time frame: Baseline, 1 month and 6 months post treatment
Assessment of Contextual Verbal Learning
Administered by study staff as a part of physician visits at baseline, and 1, and 6 months following treatment . Scores will be numerically determined and compared to baseline. Changes against baseline will be represented numerically (positive or negative)
Time frame: Baseline, 1 month post treatment and 6 months post treatment
Assessment of Verbal Fluency
Administered by study staff as a part of physician visits at baseline, and 1, and 6 months following treatment . Scores will be numerically determined and compared to baseline. Changes against baseline will be represented numerically (positive or negative). Scoring is based on total word numbers (expressed in 60 seconds), higher totals in tests indicate improvement
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Each participant in this arm will receive a single dose of placebo. Upon completion of the study each placebo participant will with be given the option to be treated with their cultured adipose derived stem cells derived from their own adipose (fat) tissue via infusion therapy delivery over the course of one hour. Dosage for the crossover will be determined by the PI following review of data collected from the other arms of the study.
Time frame: Baseline, 1 month post treatment and 6 months post treatment
Assessment of Attention and Executive functions
Administered by study staff as a part of physician visits at baseline, and 1, and 6 months following treatment . Scores will be numerically determined as the number of correct answers provided in 90 seconds. and compared to baseline. Changes against baseline will be represented numerically (positive or negative). AN increase in total correct answers will indicate improvement
Time frame: Baseline, 1 month post treatment and 6 months post treatment
Assessment of Unstructured Verbal Learning and Memory
Administered by study staff as a part of physician visits at baseline, and 1, and 6 months following treatment . Scores will be numerically determined based the total number of correct answers in 3 categories of 12 and compared to baseline as a percentage. Changes against baseline will be represented numerically (positive or negative), Improved scores will indicate improvement.
Time frame: Baseline, 1 month post treatment and 6 months post treatment
Assessment of Visuospatial Learning and Memory
Administered by study staff as a part of physician visits at baseline, and 1, and 6 months following treatment . Scores will be numerically determined (percent) based upon correct recall and compared to baseline. Changes against baseline will be represented numerically (positive or negative).
Time frame: Baseline, 1 month post treatment and 6 months post treatment
Assessment of Symptoms of Anxiety over Time
Completed by Participant as a part of physician visits at baseline, and 1, and 6 months following treatment. Each question is scored on a scale of 1 to 4 for 22 questions, total score is the sum of the score of each item (1-4) will be numerically determined and compared to baseline. Changes against baseline will be represented numerically (positive or negative). Lower scores will indicate improvement.
Time frame: Baseline, 1 month post treatment and 6 months post treatment
Assessment of Pain
Completed by Participant as a part of physician visits at baseline, and 1, and 6 months following treatment . Scores will be numerically determined on a scale of 1 to 10 and compared to baseline. Changes against baseline will be represented numerically (positive or negative) lower scores will indicate improvement.
Time frame: Baseline, 1 month post treatment and 6 months post treatment
Assessment of Sleep Quality
Completed by Participant as a part of physician visits at baseline, and 1, and 6 months following treatment. Scores will be numerically determined (1 to 3) for 7 questions (maximum score of 21) and compared to baseline. Changes against baseline will be represented numerically (positive or negative). Lower total scores indicate improvement.
Time frame: Baseline, 1 month post treatment and 6 months post treatment
Assessment of Treatment by Participant
Completed by Participant as a part of physician visits at baseline, and 1, and 6 months following treatment . Scores will be numerically determined on a 1 to 7 basis, and compared to baseline. Changes against baseline will be represented numerically (positive or negative) lower scores represent improvement.
Time frame: Baseline, 1 month post treatment and 6 months post treatment
Assessment of Depression by Participant
Completed by Participant as a part of physician visits at baseline, and 1, and 6 months following treatment . Scores will be numerically determined (1 to3) for 9 questions (maximum score of 27) and compared to baseline. Changes against baseline will be represented numerically (positive or negative), lower scores indicate improvement.
Time frame: Baseline, 1 month post treatment and 6 months post treatment