Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT01348451
Eligibility Criteria:
Inclusion Criteria:
1. Have the ability to understand the requirements of the study, provide written informed consent, understand and provide written authorization for the use and disclosure of Protected Health Information (PHI) \[per Health Insurance Portability and Accountability Act (HIPAA) Privacy Ruling\] and comply with the study procedures.
2. Subjects with sporadic or familial ALS diagnosed as laboratory-supported probable,probable or definite according to the World Federation of Neurology El Escorial Criteria (Appendix A), based on examination by the site PI.
3. Age 18 years or older.
4. Females must have a negative serum pregnancy test and practice an acceptable method of contraception or be of non-childbearing potential (post-menopausal for at least 2 years or surgically sterile \[hysterectomy, oophorectomy or surgical sterilization\]).
5. Geographic accessibility to the study center and the ability to travel to the clinic for study visits.
6. Presence of a willing and able caregiver.
7. Medically able to undergo lumbar or cervical laminectomy as determined by the Investigator, surgeon and anesthesiologist.
8. Medically able to tolerate immunosuppression regimen consisting of basiliximab, tacrolimus, mycophenolate mofetil, and methylprednisolone as determined by the site Investigator.
9. Agrees to the visit schedule as outlined in the informed consent.
10. Not taking riluzole (Rilutek®) or on a stable dose for ≥30 days.
11. All required vaccinations current: tetanus/diptheria (TDAP), herpes zoster/shingles(Vostavax®: within last 10 years and must be prior to surgery), pneumonia (Pneumovax®),seasonal/H1N1 flu vaccines (as appropriate for season) for Groups B-E.
Exclusion Criteria:
1. Etiology of paraplegia or weakness is due to causes other than ALS such as spinal ischemia, traumatic spinal injury, traumatic brain injury, multiple sclerosis, cerebral stroke, cerebral palsy, or infection.
2. VC \< 60% predicted normal by standard nomogram at the time of screening and VC \< 50% predicted normal measured supine for age at the time of surgery.
3. Current or peak Panel Reactive Antibody (PRA) due to alloantibodies \> 20% receiving their first allograft.
4. Any known immunodeficiency syndrome.
5. Receipt of any investigational drug,device or biologic within 30 days of surgery.
6. Any concomitant medical disease or condition limiting the safety to participate:
* Coagulopathy
* Active uncontrolled infection
* Hypotension requiring vasopressor therapy
* Previous spinal surgery at the site of planned transplantation except for anterior cervical dissection fusion (ACDF)
* Skin breakdown over the site of surgery
* Malignancy (except for non-melanoma skin cancer)
* Primary or secondary immune deficiency
* Spinal stenosis.
7. Creatinine \>1.5, liver function tests (SGOT/SGPT, Bilirubin, Alk Phos) \> 2x the upper limit of normal, hematocrit/hemoglobin \< 30/10, total WBC \< 4000, uncontrolled hypertension (defined as systolic \>180 or diastolic \>100) or uncontrolled diabetes(defined as hemoglobin A1C \>8), evidence of GI bleeding by hemoccult test, positive tuberculosis (TB test: PPD/Mantoux), hepatitis B or C, or human immunodeficiency virus (HIV).
8. Presence of any of the following conditions:
* Current drug abuse or alcoholism
* Unstable medical conditions
* Unstable psychiatric illness including psychosis and untreated major depression within 90 days of screening
* Positive blood test for hepatitis B or C.
9. Any condition that the site PI feels may interfere with participation in the study.
10. Any condition that the surgeon feels may pose complications for the surgery.
11. Known hypersensitivity to basiliximab, tacrolimus, mycophenolate mofetil, or methylprednisolone.
12. Inability to provide informed consent as determined by screening protocol.
13. Inadequate family or caregiver support as determined by the site PI.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01348451
Study Brief:
Protocol Section:
NCT01348451