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Intradiscal injection of autologous discogenic cells in patients with discectomy: a prospective clinical study of its safety and feasibility

Long-term outcomes of discectomy combined with autologous discogenic cells transplantation in the treatment of lumbar disc herniation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100049928
Enrollment
Unknown
Registered
2021-08-12
Start date
2012-07-01
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intervertebrl disc degeneration

Interventions

Experimental group:discectomy combined with transplantation of autologous discogenic cells
Control group:Discectomy alone

Sponsors

the Sixth Medical Center of PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
21 Years to 59 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 18 to 60 years; 2. Single-level lumbar disc herniation confirmed on MRI that was consistent with history and physical examination; 3. Clinical diagnosis of low back pain and/or sciatica; 4. Failed conservative treatment (i.e. physical therapy, medications, epidural injection,) for a minimum of 6 months.

Exclusion criteria

Exclusion criteria: 1. Previous surgery at the lumbar levels; 2. Disc re-herniation treated with nucleotomy / sequestrectomy of the relevant disc; 3. Degenerative changes in the lumbar as determined by Modic Changes 2 or 3/Pfirrmann 4 or 5; 4. Segment instability (spondylolisthesis >5mm or translation >3mm); 5. Body Mass Index> 30 kg/m2; 6. Severe cardiac disease, pulmonary disease, active neoplasm, anemia or any other surgical contraindications.

Design outcomes

Primary

MeasureTime frame
the Visual Analog Scale;the Oswestry Disability Index (ODI);The Short form health survey-36 (SF-36);Japanese Orthopaedic Association (JOA) scoring system;disc height index;the ratio value of the grayscale;

Secondary

MeasureTime frame
the apparent diffusion coefficient (ADC);Numberof CEP defects;

Countries

China

Contacts

Public ContactDike Ruan

the Sixth Medical Center of PLA General Hospital

ruandikengh@163.com+86 18600310015

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026