ATCell™ Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells Deployed Via Intravenous Infusion
Post-Concussion Syndrome
About this trial
This is an interventional treatment trial for Post-Concussion Syndrome focused on measuring Concussion, Adipose Derived Stem Cell, Mesenchymal Stem Cell, Adult Stem Cell, Traumatic Brain Injury, Athletes, Military, Chronic Concussion Syndrome, Post Concussion Syndrome
Eligibility Criteria
Inclusion Criteria:
- Reviewed and personally signed and dated informed consent document indicating that the participant (or legally acceptable representative) has been informed of and understands all pertinent aspects of the study.
Confirmed Diagnosis of Chronic Concussive Syndrome/Post-Concussive Syndrome: At least three (3) of the following criteria must be met to confirm diagnosis:
A. Persistent headaches
B. Persistent dizziness
C. Persistent fatigue
D. Irritability, intolerance to stress, or unusual emotional reactions
E. Lowered tolerance to noise and/or light
F. Impaired memory or concentration
G. Insomnia
- Female participants of child bearing potential and at risk of pregnancy during the study must agree to use 2 highly effective methods of contraception throughout the study and for 112 days after the last study visit.
Female participant who are not of childbearing potential (i.e. must meet at least one (1) of the following criteria):
i) Have undergone a documented hysterectomy and/or bilateral oophorectomy
ii) Have medically confirmed ovarian failure
iii) Achieved postmenopausal status defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or psychological cause and have a serum follicle stimulating hormone (FSH) level confirming the post menopausal state
- Individuals who are willing and able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests, and other study procedures through the end of the final study visit
- Individuals Aged 18 to 65 at the time of screening and enrollment.
Exclusion Criteria:
Any cardiac pathologies or conditions which may risk the participant or interfere with the ability to interpret the results. Signs and symptoms of clinically significant cardiac disease including but not limited to:
A. Ischemic cardiac disease (eq. unstable angina, myocardial infarction) in the 6 months prior to screening.
B. New York Heart Association (NYHA) Class III or IV congestive heart failure or known left ventricular dysfunction with ejection fraction ≤ 35%, cardiomyopathy, myocarditis in the 6 months prior to screening.
C. Resting tachycardia (heart rate ≥ 120) or resting bradycardia (heart ≤ 45) on ECG at screening.
D. Any other cardiovascular illness that in the opinion of the Investigator would render an individual unable to participate in the study.
E. Individuals with history of heart block.
F. Individuals with a history of Atrial Fibrillation
G. Individuals that have had stents implanted within one year of recruitment
- History of transient ischemic attack in the 6 months prior to screening, diagnosis of stroke with residual deficits (eq. aphasia, substantial motor or sensory deficits) diagnosis of stroke with residual deficits (eq. aphasia, substantial motor or sensory deficits) that would preclude completion of required study activities
- Resting, sitting blood pressure (BP) ≥ 160 mm Hg in systolic pressure or ≥ 100 mm Hg in diastolic pressure at screening. If a participant is found to have untreated significant hypertension at screening and antihypertensive treatment is initiated, assessment for study eligibility should be deferred until BP and antihypertensive medication have been stable for at least 1 month. For participants with previously diagnosed hypertension, antihypertensive medications must be stable for at least 1 month prior to screening
- Participants who have evidence of orthostatic hypotension based upon replicate orthostatic blood pressure measurements. If orthostatic blood pressure change is not able to be determined (e.g., unable to establish a stable supine systolic and diastolic blood pressure) the participant is not eligible for the study
- Individuals with a history of Deep Vein Thrombosis (DVT) or pulmonary embolism
- Individuals with a history or family history of thrombophilia such as Factor V Leiden
- Individuals that have had stents implanted within the past year
- Individuals that are currently being treated with an anticoagulant medication
History, diagnosis, or signs and symptoms of clinically significant neurological disease, including but not limited to:
A. Alzheimer's disease or other type of dementia
B. Peripheral or autonomic neuropathy
C. Multiple sclerosis
D. Epilepsy or seizure disorder with history of seizure within the last 2 years
E. Myopathy
F. White matter disease
Individuals currently being treated with specific prescription immunomodulatory agents:
A. Certolizumab (Cimzia™)
B. Infliximab (REMICADE™)
C. Etanercept (Enbrel™)
D. Prednisone (Deltasone, Rayos, Prednisone Intensol)
E. Prednisolone (Omnipred™)
F. Dexamethasone (Ozurdex™)
G. Any drug which the investigator believes would compromise the results or interfere with ATCell™ effectiveness
- Participant with any active or chronic infection
- Life-threading organ dysfunction
- Planned surgical procedure during the duration of the study
- Largely or wholly incapacitated (eq. individual bedridden or confined to wheelchair, permitting little or no self care)
- Pregnant or actively breastfeeding females; females of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study, meaning 6 months after ATCell™ administration
- Severe physical limitations or disabilities
- Participants who are seropositive for Human Immunodeficiency Virus -1 (HIV1), Human Immunodeficiency Virus -2 (HIV2), Hepatitis B Surface Antigen and Hepatitis C, indicative of current infection
- Participant unable to give written consent in accordance with institutional review board guidelines
- Treatment with any immunosuppressive therapy within 3 months of evaluation
- Current or recent treatment (within 3 months of evaluation) with an investigational drug and/or therapy (phase 1-4) within 90 days of screening
- Individuals with a concurrent diagnosis of malignant neoplasm (cancer)
- History of cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
- Individuals with inadequate subcutaneous tissue to allow for appropriate lipoaspirate collection
- Other severe or chronic medical psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make this individual inappropriate for entry into this study
- Individuals with immunodeficiencies or severe autoimmune disease
- Individuals allergic to local anesthetics
- Individuals with any contraindication to liposuction, in the investigator's opinion
- History of coagulation disorders that would put them at risk
- Individuals, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason
- The individual is involved in an active civil, criminal or workers compensation case other than the NFL class action
- Individuals unable or unwilling to return for the required follow-up evaluations
- Presence of drugs of abuse (including cannabis and prescription medications without valid prescription), or illegal drugs in the urine toxicology test obtained at screening
- History of known alcohol, analgesic or drug abuse within 2 years of screening
- Individuals who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or who are employees directly involved in the conduct of the study
Sites / Locations
- BioSolutions Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
50 million cell infusion
150 million cell infusion
300 million cell infusion
Placebo
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.
Each participant in this arm will receive a single dose of placebo. Upon completion of the study each placebo participant 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.