ATCell™ Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells Deployed Via Intravenous Infusion
Status unconfirmed · Phase 1 · Has a placebo group
Conditions studied: Post-Concussion Syndrome
In brief
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).
Key facts
- Study ID
- NCT04744051
- Run by
- American CryoStem Corporation
- People needed
- 20
- Starts
- 2021-02-01
- Expected to finish
- 2024-01-31
- Last updated by the study team
- 2023-06-09
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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™)
Where it is running
- BioSolutions Clinical Research Center — La Mesa, California, United States
Full record on ClinicalTrials.gov
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