Dose Escalation Pilot Study to Evaluate the Safety of Alocyte for the Treatment of Facetogenic Back Pain
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlimorad Farshchian
About this trial
The purpose of this study is to see if the use of Alocyte (cord blood plasma plus mononucleic cells) will be safe, well tolerated, and whether it causes any side effects. The study will also examine if the use of the Investigational Product (IP) is able to reduce local inflammation or alleviate Facetogenic back pain
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects age > 18 years at the time of signing the Informed Consent Form.
Male or Female.
Ability of participant to understand and the willingness to sign a written informed consent document.
Facetogenic back pain diagnosed using the following diagnostic criteria Subjects who have chronic low back pain based on clinical evaluation. Pain onset at dorsal extension and release at flexion is often considered suggestive for facet pain, even if non-specific, such as maximal tenderness upon deep palpation of posterior elements.
Disqualifiers
Previous surgical intervention for back pain
Previous stem cell injection(s) within the last year
Use of anticoagulation or NSAIDs within 5 days of the injection
MRI finding of severe high-grade lumbar stenosis
Trial design
Design model
Sequential
Treatments tested in this trial
Alocyte low dose
DrugLow dose containing 0.2 - 1.0 x 10\^11 particles and 3-10x10\^6 cell in 2mL which will be administered intra-facet into a single facet joint. Preparation of low dose: 1ml of Alocyte will be diluted with 9ml of saline. After mixing well, only 2ml of the diluted product will be used.
Alocyte medium dose
DrugMedium dose containing 0.6 - 3.0 x 10\^11 particles and 9-30x10\^6 cell in 6mL which will be administered intra-facet into three facet joints delivering 2ml/facet joint. Preparation of medium dose: 1ml of Alocyte will be diluted with 9ml of saline. After mixing well, only 6ml of the diluted product will be used.
Alocyte high dose
DrugHigh dose containing 1.0 - 5.0 x 10\^11 particles and 15-50x10\^6 cell in 10mL which will be administered intra-facet into five facet joints delivering 2ml/facet joint. Preparation of high dose: 1ml of Alocyte will be diluted with 9ml of saline. After mixing well, 10ml of diluted product will be used.
Treatment groups
15 Participants
are divided into 3 treatment groupsGroup A: Alocyte Low doseExperimental treatment 1 intervention
Group B: Alocyte Medium doseExperimental treatment 1 intervention
Group C: Alocyte High doseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of Alocyte treatment adverse events
To evaluate safety ( incident of grade 3 or 4 or treatment emergent serious adverse events) of Alocyte administered in subjects experiencing Facetogenic back pain at a low, medium and high dose.
Time frame
through study completion, an average of 13 months2
Incidence of treatment emergent adverse events as assessed by complete blood count safety lab tests
To evaluate the incidence of treatment emergent adverse events as assessed by safety lab blood sample test complete blood count (CBC with differential)
Time frame
at 1 month3
Incidence of treatment emergent adverse events as assessed by complete blood count safety lab tests
To evaluate the incidence of treatment emergent adverse events as assessed by safety lab blood sample test complete blood count (CBC with differential)
Time frame
at 3 months4
Incidence of treatment emergent adverse events as assessed by complete blood count safety lab tests
To evaluate the incidence of treatment emergent adverse events as assessed by safety lab blood sample test complete blood count (CBC with differential)
Time frame
at 6 months monthsSecondary outcomes
1
Efficacy of Alocyte treatment as assessed by the change in Quality of Life (QoL) SF-12 questionnaire
Change from baseline in subject QoL SF-12 questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Time frame
baseline, 1 month, 3 months, 6 months, 12 months2
Efficacy of Alocyte Treatment for pain management as assessed by the change in Numeric Rating Scale (NRS) pain scale
Change between baseline in pain using the Numeric Rating Scale (NRS) on a scale from 0 (equals no pain) to 10 (worst pain imaginable)
Time frame
baseline, 1 month, 3 months, 6 months, 12 months3
Efficacy of Alocyte Treatment for pain as assessed by the change in the Owestry Back Pain questionnaire
Change between baseline in back pain using Oswestry Low back pain questionnaire made up of 10 questions. Each question is scored from 0-5 (minimum to maximum).
Time frame
baseline, 1 month, 3 months, 6 months, 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Alimorad Farshchian
Lead sponsor
The Center For Regenerative Medicine Laboratories
Sponsor institution
Source ClinicalTrials.gov