| Eligibility |
Inclusion Criteria:
1. Signed Informed Consent Form
2. Male or female, between 18 and 80 years of age, inclusive
3. Clinical indication: Lumbar disk disease with no prior lumbar surgery with radicular
pain symptoms and/or signs of compressive neuropathy
4. At screening and baseline, a pain intensity score > 60 using the visual analog scale
of pain intensity [VASPI] (0-100 mm scale) and a participant reported history of pain
in the past 3 or more months
5. Medically stable as determined by the Principal Investigator in consultation with the
Sponsor's Medical Monitor, based on pre-study medical history, physical examination,
and clinical laboratory tests
6. In the judgment of the Principal Investigator, acceptable vital signs: blood pressure;
resting heart rate; respirations, and oral temperature
7. Life expectancy >6 months as determined by the Principal Investigator
8. Female participants of child-bearing potential, and those <1 year post-menopausal,
must be practicing highly effective methods of birth control such as hormonal methods
(e.g., combined oral, implantable, injectable, or transdermal contraceptives), double
barrier methods (e.g., condoms, sponge, diaphragm, or vaginal ring plus spermicidal
jellies or cream), or total abstinence from heterosexual intercourse for a minimum of
1 full menstruation cycle before study drug administration and agree to continue
abstinence for 1 full menstruation cycle after the study is completed
9. Male participants who are heterosexually active, and not surgically sterile, must
agree to use effective contraception for the duration of the study and for 1 month
after the study is completed
10. Stable medical regimen for =1 month before screening assessments
11. Have suitable lumbar anatomy for intrathecal injection as determined by MRI or X-Ray
in the last 6 months.
12. Willing and able to return for the follow-up (FU) visits
13. Able to read and understand study instructions, and willing and able to comply with
all study procedures
14. Adequately informed of the nature and risks of the study and give written informed
consent before receiving any study specific assessments or procedures
15. Stable use of non-prescription pain therapy, including massage, TENS, physiotherapy
osteopathy, chiropractic and acupuncture for 2 months prior and throughout the study
period
Exclusion Criteria:
Participants must NOT meet any of the following exclusion criteria:
1. Hypersensitivity, allergy, or significant reaction to any ingredient of the study drug
2. Any spinal deformity preventing intrathecal injection or making intrathecal injection
unsafe
3. Prior history of lumbar surgery, including fusion and microdiscectomy
4. History of epidural block or facet block or steroid injection in the last 6 months
5. Current unstable angina, uncontrolled congestive heart failure, or >1+ pitting edema
of lower extremities
6. History of acute myocardial infarction, transient ischemic attack, stroke, or seizure
within 3 months of screening visit
7. Severe chronic obstructive or restrictive pulmonary disease
8. Current insulin dependent diabetes mellitus
9. Current autoimmune conditions or documented immunodeficiency
10. History of immunosuppressive therapy; high-potency systemic steroids in the last 3
months
11. Current treatment with systemic immunosuppressive (systemic corticosteroid therapy
[equivalent to >10mg/day prednisone] or other strong immunosuppressant)
12. Current or history of central nervous system cancer
13. Any malignancy (EXCEPTION: localized non-melanoma skin cancers) within 5 years before
the screening visit or currently receiving systemic chemotherapy, radiation therapy,
or a surgical stabilization procedure
14. Significant hepatic disease as indicated by clinical laboratory results for the
following: =3 times the upper limit of normal (ULN) for aspartate aminotransferase,
alanine aminotransferase, = 2.5 time ULN alkaline phosphatase, or =1.5 times ULN for
total bilirubin)
15. Severe anemia (Grade 3; hemoglobin <8.0 g/dL, <4.9 mmol/L, <80 g/L; transfusion
indicated), Grade 1 white cell counts (lymphocytes <LLN - 800/mm3; <LLN - 0.8 x 109
/L, neutrophils <LLN - 1500/mm3; <LLN - 1.5 x 109 /L)
16. Significant renal disease as indicated by creatinine =1.5 times the upper limit of
normal or creatinine clearance <80 mL/minute (Cockcroft-Gault formula estimate)
17. Confirmed positive for human immunodeficiency virus, hepatitis B virus, or hepatitis C
virus
18. Significant psychological conditions; dementia, major depression, or altered mental
state that in the opinion of the Investigator will interfere with study participation
19. Current treatment with systemic antibiotics or antivirals (EXCEPTION: topical
treatments)
20. Current treatment with anticoagulants /antiplatelet medications except for low dose
aspirin or low dose aspirin-containing compounds. Participants, if medically feasible,
can interrupt anticoagulant therapy by following local medical practice protocol for
intrathecal injections for participants on anticoagulant, antiplatelet therapy.
21. Current use of systemic corticosteroids (equivalent to >10mg/day prednisone)
22. Known or suspected history of active alcohol or illicit drug abuse within 1 year
before the screening visit
23. Women who are pregnant or nursing
24. Use of any investigational drug or device within 1 month before randomization or
current participation in a trial that included intervention with a drug or device; or
currently participating in an investigational drug or device study
25. Any condition that, in the opinion of the Principal Investigator, could compromise the
safety of the participants, the participant's ability to communicate the study staff,
or the quality of the data
26. Presence of an implanted intrathecal infusion system or peripheral neurostimulator
27. Presence of a generalized pain disorder such as fibromyalgia or complex regional pain
syndrome that in the opinion of the PI may impact on evaluation of response to the
study drug
28. Diagnosis of peripheral neuropathy of the lower extremities which in the opinion of
the PI, might interfere with the participant's ability to assess the effect of the
study drug on the radicular signs and/or symptoms
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