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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.
Full 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.
Enrollment
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Inclusion criteria
• Patient must
Exclusion criteria
• Patient must not
Primary purpose
Allocation
Interventional model
Masking
100 participants in 1 patient group
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Central trial contact
Katherine Minter-Dykhouse, PhD; David L Greene, MD, PhD, MBA
Data sourced from clinicaltrials.gov
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