Summary
This is a Pilot Study that is an open label, prospective, non-controlled study in which the safety and feasibility of Wharton's Jelly (WJ) allograft will be evaluated in 100 participants suffering with low back pain.
Detailed Description
This is a prospective, open label, non-controlled Pilot study in which the safety and feasibility of umbilical cord Wharton's Jelly (WJ) allograft will be evaluated in participants suffering with lumbar pain. The participants will receive a series of lumbar injections described in the protocol.
As this is a Pilot study primarily designed to evaluate safety, no control will be used. The dosing will consist of 10cc WJ Allograft with 100 total participants. In addition to baseline outcome instruments along with imaging and laboratory studies, participants will be followed for one year for evaluation of safety, pain relief and functional improvements.
Eligibility Criteria
Age Range: 20 years to No maximum
Inclusion Criteria:
• Patient must
* Be over age 20.
* Suffering from chronic lumbar pain
* Body Mass Index (BMI) \<50 Kilograms/m2.
* Pain score of 4 or more on the Numeric Pain Rating Scale (NPRS).
* Female participants must be abstinent, surgically sterilized or postmenopausal.
* Premenopausal females must be on contraceptive measures and do not anticipate pregnancy during the duration of the study.
* Be willing and capable of giving written informed consent to participate in English.
* Be willing and capable of complying with study-related requirements, procedures and visits.
Exclusion Criteria:
• Patient must not
* Have taken any pain medication including nonsteroidal anti-inflammatory drugs (NSAIDs) within 2 weeks prior to study injection date.
* Use anticoagulants have a substance abuse history, and fail to agree not to take any lumbar symptom modifying drugs during the course of the study without discussing and reporting the use to the site Clinical investigator and study team.
* Known allergy to penicillin, sulfa or amphotericin medications.
* Have had any lumbar injections (at all) of any drug in lumbar spine in the past 6 months.
* Have had surgery on the lumbar spine within the past 6 months.
* Had a traumatic injury to the lumbar spine with the past 3 months.
* Planned elective surgery during the course of the study.
* A history of organ or hematologic transplantation, rheumatoid arthritis, or other autoimmune disorders.
* Be on immunosuppressive medications.
* Have a diagnosis of carcinoma with the past 5 years.
* Have a lumbar infection or have used antibiotics for lumbar infection within the past 3 months.
* Have participated in any other clinical study or treatment (not just for the lumbar spine, but for any reason) with any investigational product within the past 30 days prior to inclusion of study.
* Female participants who are breast feeding or are pregnant or desire to become pregnant during the course of the study.
* Contraindications to radiographic or MRI imaging.
* Serious neurological, psychological or psychiatric disorders.
* Injury or disability claims under current litigation or pending or approved workers compensation claims.
Interventions
BIOLOGICAL
Lumbar Injections with 10cc's of Wharton's Jelly Allograft