ATCell™ Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells Deployed Via Intravenous Infusion

• Status: Recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American CryoStem Corporation

Criteria

Inclusion Criteria:

1. 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.

2. 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

3. 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.

4. 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

5. 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

6. Individuals Aged 18 to 65 at the time of screening and enrollment.

Exclusion Criteria:

1. 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

2. 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

3. 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

4. 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

5. Individuals with a history of Deep Vein Thrombosis (DVT) or pulmonary embolism

6. Individuals with a history or family history of thrombophilia such as Factor V Leiden

7. Individuals that have had stents implanted within the past year

8. Individuals that are currently being treated with an anticoagulant medication

9. 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

10. 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

11. Participant with any active or chronic infection

12. Life-threading organ dysfunction

13. Planned surgical procedure during the duration of the study

14. Largely or wholly incapacitated (eq. individual bedridden or confined to wheelchair, permitting little or no self care)

15. 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

16. Severe physical limitations or disabilities

17. 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

18. Participant unable to give written consent in accordance with institutional review board guidelines

19. Treatment with any immunosuppressive therapy within 3 months of evaluation

20. Current or recent treatment (within 3 months of evaluation) with an investigational drug and/or therapy (phase 1-4) within 90 days of screening

21. Individuals with a concurrent diagnosis of malignant neoplasm (cancer)

22. History of cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision

23. Individuals with inadequate subcutaneous tissue to allow for appropriate lipoaspirate collection

24. 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

25. Individuals with immunodeficiencies or severe autoimmune disease

26. Individuals allergic to local anesthetics

27. Individuals with any contraindication to liposuction, in the investigator's opinion

28. History of coagulation disorders that would put them at risk

29. 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

30. The individual is involved in an active civil, criminal or workers compensation case other than the NFL class action

31. Individuals unable or unwilling to return for the required follow-up evaluations

32. Presence of drugs of abuse (including cannabis and prescription medications without valid prescription), or illegal drugs in the urine toxicology test obtained at screening

33. History of known alcohol, analgesic or drug abuse within 2 years of screening

34. 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