Autologous adipose-derived mesenchymal stem cells in vitro expanded for Degenerative disc disease

Inclusion criteria

• {"criterion_text":"- Patients with lumbar back pain (max 2 levels)\n- age 20 to 60 yrs,\n- moderate disc degeneration (Pfirman grade 2-3)"}

Exclusion criteria

• {"criterion_text":"- Patients with lumbar back pain of other apparent reason such as: severe spinal stenosis, herniated disc, spondylolisthesis grade 2 or more.\n- Penicillin allergies.\n- Age <20yrs, >60 yrs.\n- Cognitive impairment.\n- Treatment with cytostatic drugs.\n- High risk of bleeding (bleeding disorder, taking anticoagulants etc.).\n- Previous injections in disc.\n- Pregnancy or breastfeeding.\n- Conditions not compatible with MRI (non-compatible implants, claustrophobia, severe obesity).\n- Tumors, infection or fracture in spine."}

Primary endpoints

• {"endpoint_text":"- Treatment success, pain reduction compared to control group Timeframe 2 yr, no post-intervention on treated level. No unexpected events by procedure.\n- VAS-score\n- pain diary\n- EQ-5D\n- ODI\n- SF-36\n- LBPRS","definition_or_measurement_approach":"- Treatment success: Timeframe 2 yr, no post-intervention on treated level. No unexpected events by procedure.\n- VAS-score: \n- pain diary: \n- EQ-5D: \n- ODI: \n- SF-36: \n- LBPRS: "}

Secondary endpoints

• {"endpoint_text":"- MR morphology of disc: height, water content, fat and lipid, lactose, glucose, proteoglycans, collagen.","definition_or_measurement_approach":"- MR morphology of disc: height, water content, fat and lipid, lactose, glucose, proteoglycans, collagen."}

Denmark

Earliest CTIS Part Ii Submission Date

08-10-2024

Latest Decision Or Authorization Date

27-05-2025

Processing Time Days

231

Number Of Sites

1

Number Of Participants

34

Primary sponsor

Full Name

Aarhus Universitet

Organisation Type

Educational Institution

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"Codes: 1,9","organisation_type":"Educational Institution"}
• {"country":"Denmark","full_name":"Region Midtjylland","duties_or_roles":"Codes: 14,4","organisation_type":"Hospital/Clinic/Other health care facility"}