The Safety/Efficacy Study of Human Umbilical Cord Mesenchymal Stem Cells Therapy (19#iSCLife®-LDP) for Lumbar Discogenic Pain

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSclnow Biotechnology Co., Ltd.

About this trial

This experimental use umbilical cord mesenchymal stem cells in treatment of the early stage of lumbar discogenic pain (endogenous pain of the disc) to evaluate its safety and efficacy.

This experimental is mainly aimed at over 18years old people, regardless of gender, with refractory and persistent back pain for more than 6 months.

The efficacy and safety of mesenchymal stem cells (MSCS) were evaluated by low-temperature plasma ablation and intravertebral disc injection, which were divided into treatment group and control group.

Eligibility criteria

Qualifiers

age over 18

refractory and persistent lumbago pain for more than 6 months, with/without radiation pain in lower limbs, and poor conservative treatment effect;

the straight leg elevation test was 70 degrees negative;

MRI of lumbar spine showed herniated disc < 6 mm, no obvious compression of spinal cord and nerve roots; T2-weighted mri of the lumbar spine showed decreased single/multi-segment signal (black disc sign) or High signal zone (HIZ) in the posterior part of the intervertebral disc annulus.

Disqualifiers

coagulation dysfunction or anticoagulant therapy;

intervertebral space infection, puncture site infection or systemic infection;

lumbago pain of non-spinal origin, such as sacroiliac joint origin pain;

patients who have had open surgery or other disc treatments;

Trial design

Treatments tested in this trial

  • human umbilical cord mesenchymal stem cell

Treatment groups

242 Participants
are divided into 2 treatment groups

Sponsors and collaborators