Safety of intradiscal injection of nucleus pulposus derived stromal cells in regeneration of human degenerated lumbar disc in patients with chronic low back pain

Royan Institute0 个研究点目标入组 5 人开始时间: 待定最近更新: 2022年11月21日

试验速览

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•Age between 18 and 65 years
•Of both sexes
•Degenerative intervertebral disc in one or two lumbar intervertebral discs with pain that has not responded to previous supportive therapies, including the use of conventional analgesics or physiotherapy within the last 6 months.
•The fibrous ring is able to hold the injected cell based on the discography performed. This means that stage of the disease must be 2,3 or 4 and stage 5 cannot be included in the study.
•Reduction of intervertebral disc height by 50% or more based on radiography.
•Do not have a vertebral infection.
•Have no uncontrolled chronic underlying disease that is prohibited for treatment.
•Have no uncontrolled chronic underlying disease that is prohibited for treatment.
•Do not be pregnant or breastfeeding women.
•Not positive and transmissible viral infection.

•infection signs or positive serology for HIV, hepatitis and syphilis
•allergy to gentanicin, or to bovine, cattle or horse serum
•congenital or acquired disease leading to spine deformities that may upset cell application
•spinal segmental instability, spinal canal stenos, isthmus pathology, and other conditions that may compromise the study
•modic 3 changes on MRI images
•overweight with body mass index greater than 30.5
•immunosuppression
•participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study
•other conditions that may, according to medical criteria, discourage participation in the study.

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