Cleveland

Researchers are evaluating the safety and feasibility of injecting Wharton's Jelly (WJ) allograft directly into the knee joint of patients with knee osteoarthritis (OA). This pilot study is randomized, prospective, and open-label, focusing on dose escalation without a control group. It includes patients aged 30 and older with moderate knee OA. The study aims to observe safety and possible improvements in pain and function over one year. Participants will be randomly assigned to receive one of three doses of WJ allograft in a single knee injection: 2cc (low dose), 3cc (medium dose), or 4cc (high dose). A total of 120 patients will be evenly divided among these three groups. No placebo or control group is included since the primary goal is to assess safety. The treatment is administered as a direct injection into the affected knee joint. Throughout the study, participants will undergo various assessments including blood tests measuring inflammation and organ function at baseline, 1 week, 6 weeks, 3 months, 6 months, and 1 year after treatment. They will also complete pain and functional questionnaires at regular intervals to track changes. The study includes imaging and laboratory evaluations to monitor safety, pain relief, and functional improvements during the one-year follow-up period.

Researchers are evaluating the safety and feasibility of using umbilical cord Wharton's 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.