Efficacy of discal injection of cells produced in the bone marrow in subjects withchronic back pain caused by a degenerative disease of the vertebrae unresponsive toconventional therapy
- Conditions
- Degenerative Disc DiseaseMedDRA version: 21.0Level: LLTClassification code 10070241Term: Degenerative disc diseaseSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2017-002092-25-IT
- Lead Sponsor
- CENTRE HOSPIITALIIER UNIIVERSIITAIIRE DE MONTPELLIIER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 112
-Age between 18 and 60 years.
-Symptomatic chronic low back pain unresponsive to conservative therapy (including
physical therapy performed during at least 1 month before inclusion and pain medication
with level 2 analgesics in failure or intolerant to level during at least 1 month) for
at least 3 months.
-DDD assessed by (Pfirrmann’s score modified Griffith et al) grade 4 to 7 at one level.
If second level, it should be adjacent (Pfirrmann’s score 1-4 maximum)
-Low back Pain baseline > 40 mm on VAS (0-100).
-NSAID washout of at least 2 days before screening
-Painkillers washout of at least 24 hours before screening
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 112
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-Congenital or acquired diseases leading to spine deformations that may upset cell
application (hyperlordosis, scoliosis, isthmus lesion, sacralization and
hemisacralization).
-Symptomatic posterior lumbo-articular osteoarthritis or predominant facet syndrome on
Xray or MRI (osteophyte and facet hypertrophy).
-Prior to the screening visit, has received:
o Oral corticosteroid therapy within the previous 3 months, OR
o Intramuscular, intravenous or epidural corticosteroid therapy within the previous 3
months
-Spinal segmental instability (defined by lumbar dynamic X-Ray in extension/flexion with
antero-post translation > 3 mm and/or angular mobility > 15°).
-Spinal canal stenosis (Schizas score > B).
-History of spinal infection.
-Lumbar disc herniation with non truncated sciatica or cruralgia, as well as lumbar
cysts and radiculopathy
-Previous discal puncture or previous spine surgery.
-DDD on 3 levels, or DDD on 2 levels but not adjacent, or DDD with modic 2 or 3 phases
-Patients not eligible to the intravertebral disc surgery
-Patients who have the risk to undergo a surgery in the next 6 months
Obesity with body mass index (BMI in Kg/size in m2) greater than 35 (obesity grade II).
-Participation in another clinical trial or treatment with another investigational
product within 30 days prior to inclusion in the study.
-Abnormal blood tests: hepatic (alanine aminotransferase [ALT] and/or aspartate
aminotransferase [AST] >1.5 × upper limit of normal [ULN]), renal, pancreatic or biliary
disease, blood coagulation disorders, anemia or platelet count of <100 × 109/L.
-Significant medical problems, such as uncontrolled hypertension, symptomatic heart
failure; or any other clinically relevant condition or current medication that in the
opinion of the investigator contra-indicates the use of any of the study or rescue
medications.
-Pregnant or lactating women, or premenopausal women not using an acceptable form of
birth control, are ineligible for inclusion. Specific recommendations for contraception
and pregnancy testing is included in the information provided in the IB.Contraception
will be maintained during treatment and until the end of relevant systemic exposure.
Additional pregnancy testing will be performed at the end of relevant systemic
exposure.The patients will be required to use contraception for 2 years until the study
has completed.
-In each case of delayed menstrual period (over one month between menstruations)
confirmation of absence of pregnancy is strongly recommended. Methods that can achieve a
failure rate of less than 1% per year when used consistently and correctly are
considered as highly effective birth control methods. Such methods include:
combined (estrogen and progestogen containing) hormonal contraception associated with
inhibition of ovulation : oral, intravaginal, transdermal
progestogen-only hormonal contraception associated with inhibition of ovulation : oral,
injectable, implantable; intrauterine device (IUD);
intrauterine hormone-releasing system ( IUS);
bilateral tubal occlusion; vasectomised partner
sexual abstinence are ineligible for inclusion.
-Positive serology for following infection: Syphilis, HIV, Hepatitis B, or C.
-Contraindication to MRI assessed by the investigator.
-Intolerance or allergy to local anaesthesia.
-Any history of Cancer or immunodeficiency disease.
-Previous transfusion or transplantation.
-Current sick leave due to work accident .
-Prisoners or subjects who are involuntary incarce
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method