Treatment of degenerative disc disease
Conditions
Interventions
Product Name: Mesenquimal stem cells
Product Code: MSV
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: ringer lactate solution
CAS Number: 8026-79-7
Other descriptive name: RINGER'S
Sponsors
Citospin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Lumbar degenerative disc disease of one or two disks with predominant low back pain and / or sciatica persisting after conservative treatment (medical and physiotherapy) over 6 months. 2. Full annulus, capable of holding cell implantation, demonstrated in the MR image (stages 2, 3 and 4 of Adams) (Adams et al., 2000). 3. Decreased disc space height of more than 20% measured radiographically in lateral view. 4. Absence of spinal infection. 5. Hematological and biochemical analysis without significant alterations that contraindicate surgery 6. The patient is able to understand the nature of the study. 7. Written informed consent of the patient. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range ;Inclusion criteria: 1. Lumbar degenerative disc disease of one or two disks with predominant low back pain and / or sciatica persisting after conservative treatment (medical and physiotherapy) over 6 months. 2. Full annulus, capable of holding cell implantation, demonstrated in the MR image (stages 2, 3 and 4 of Adams) (Adams et al., 2000). 3. Decreased disc space height of more than 20% measured radiographically in lateral view. 4. Absence of spinal infection. 5. Hematological and biochemical analysis without significant alterations that contraindicate surgery 6. The patient is able to understand the nature of the study. 7. Written informed consent of the patient. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range ;Inclusion criteria: 1. Lumbar degenerative disc disease of one or two disks with predominant low back pain and / or sciatica persisting after conservative treatment (medical and physiotherapy) over 6 months. 2. Full annulus, capable of holding cell implantation, demonstrated in the MR image (stages 2, 3 and 4 of Adams) (Adams et al., 2000). 3. Decreased disc space height of more than 20% measured radiographically in lateral view. 4. Absence of spinal infection. 5. Hematological and biochemical analysis without significant alterations that contraindicate surgery 6. The patient is able to understand the nature of the study. 7. Written informed consent of the patient. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Age under 18 or over 75 or legally dependent 2. Allergies gentamicin or bovine sera, bovine or equine. 3. Congenital or acquired deformities of the spine significant obstacles to the application. 4. Pathology conditional spinal segmental instability, spinal canal stenosis, isthmus pathology and other disturbances that might compromise the study at the discretion of the investigators 5. Presence of Modic changes III in MRI images (Modic & Ross, 2007) 6. Excess weight with body mass index (BMI) greater than 35 7. Pregnancy or breastfeeding 8. neoplastic disease 9. Immunosupresive situation. 10. Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study. 11. Any other condition or circumstance that would compromise participation in the study medically ;Exclusion criteria: 1. Age under 18 or over 75 or legally dependent 2. Allergies gentamicin or bovine sera, bovine or equine. 3. Congenital or acquired deformities of the spine significant obstacles to the application. 4. Pathology conditional spinal segmental instability, spinal canal stenosis, isthmus pathology and other disturbances that might compromise the study at the discretion of the investigators 5. Presence of Modic changes III in MRI images (Modic & Ross, 2007) 6. Excess weight with body mass index (BMI) greater than 35 7. Pregnancy or breastfeeding 8. neoplastic disease 9. Immunosupresive situation. 10. Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study. 11. Any other condition or circumstance that would compromise participation in the study medically ;Exclusion criteria: 1. Age under 18 or over 75 or legally dependent 2. Allergies gentamicin or bovine sera, bovine or equine. 3. Congenital or acquired deformities of the spine significant obstacles to the application. 4. Pathology conditional spinal segmental instability, spinal canal stenosis, isthmus pathology and other disturbances that might compromise the study at the discretion of the investigators 5. Presence of Modic changes III in MRI images (Modic & Ross, 2007) 6. Excess weight with body mass index (BMI) greater than 35 7. Pregnancy or breastfeeding 8. neoplastic disease 9. Immunosupresive situation. 10. Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study. 11. Any other condition or circumstance that would compromise participation in the study medically
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Feasibility and security of MSV cells local use for degenerative disc disease treatment.;Secondary Objective: - Efficacy of treatment with MSV allogenic cells. - Monitoring the progress of discal dehydration by MRI T2 calibrated. - compare the efficacy of treatments in experimental and control arms.;Primary end point(s): The objective is to evaluate the efficacy by clinical criteria (visual evaluation Lumbar pain Visual Analog Scale (VAS) Oswestry Disability Index - ODI - index of quality of life - SF-12 -), and imaging (MRI quantitative) at 6 and 12 months of intervention.;Timepoint(s) of evaluation of this end point: 12 months;Main Objective: Feasibility and security of MSV cells local use for degenerative disc disease treatment.;Secondary Objective: - Efficacy of treatment with MSV allogenic cells. - Monitoring the progress of discal dehydration by MRI T2 calibrated. - compare the efficacy of treatments in experimental and control arms.;Primary end point(s): The objective is to evaluate the efficacy by clinical criteria (visual evaluation Lumbar pain Visual Analog Scale (VAS) Oswestry Disability Index - ODI - index of quality of life - SF-12 -), and imaging (MRI quantitative) at 6 and 12 months of intervention.;Timepoint(s) of evaluation of this end point: 12 months;Main Objective: Feasibility and security of MSV cells local use for degenerative disc disease treatment.;Secondary Objective: - Efficacy of treatment with MSV allogenic cells. - Monitoring the progress of discal dehydration by MRI T2 calibrated. - compare the efficacy of treatments in experimental and control arms.;Primary end point(s): The objective is to evaluate the efficacy by clinical criteria (visual evaluation Lumbar pain Visual Analog Scale (VAS) Oswestry Disability Index - ODI - index of quality of life - SF-12 -), and imaging (MRI quantitative) at 6 and 12 months of intervention.;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): no applicable;Timepoint(s) of evaluation of this end point: no applicable;Secondary end point(s): no applicable;Timepoint(s) of evaluation of this end point: no applicable;Secondary end point(s): no applicable;Timepoint(s) of evaluation of this end point: no applicable | — |
Countries
Spain
Contacts
Public ContactJavier Soriano Ventura;Javier Soriano Ventura;Javier Soriano Ventura ;;
Fundacion Teofilo Hernando;Fundacion Teofilo Hernando;Fundacion Teofilo Hernando
Outcome results
None listed