Pilot Study to Assess Safety and Feasibility of Umbilical Cord Whartons Jelly Allograft Injections for Chronic Low Back Pain

What this Trial Is About

Researchers are evaluating the safety and feasibility of using umbilical cord Whartons Jelly WJ allograft injections for people suffering from chronic low back pain. This pilot study is open label and non-controlled, involving 100 participants. It aims primarily to assess safety while also monitoring pain relief and functional improvements over one year. Participants will receive a series of lumbar injections containing 10cc of WJ allograft. There is no control group, and the study is designed as a phase 1 trial. The treatment involves minimal manipulation of umbilical cord tissue delivered directly to the lumbar area as described in the protocol. Throughout the study, participants will undergo baseline assessments including outcome questionnaires, imaging, and laboratory tests. Safety and efficacy will be monitored through blood tests for inflammation and organ function at baseline and multiple follow-up points up to one year. Pain and function will also be tracked using various surveys and scales at scheduled intervals. The total study duration for each participant is one year.

Safety and Feasibility of Umbilical Cord Wharton's Jelly Allograft Injections for Lumbar Pain