Cell Therapy for IBM by Muscle Injection of ADSVF
Sponsored by Assistance Publique - Hôpitaux de Paris
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended a year ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- With an age ≥ 45 and ≤ 80 yo.
- Man or menopausal woman. - With IBM defined by the Lloyd criteria (Lloyd et al., 2014): muscle weakness of finger flexors or quadriceps, and endomysial inflammatory infiltrates on muscle biopsy, and presence of invaded fibers or rimmed vacuoles on muscle biopsy.
- Who gave their written informed consent
- Affiliated to a social security regime (expected AME) And for: -group 1: treated by sirolimus since at least 6 months (but still disabled ) - group 2: currently (for at least 3 months) without specific treatment for inclusion myositis.
Exclusion Criteria
- Impossibility to walk 10 meters
- Grip evaluated by MRC5 MMT at 0 OR 1.
- Body mass index < 18
- Not able to stop any anticoagulant, or antiaggregant drugs within the week before and the 48 hours before the liposuction
- Severe respiratory insufficiency (FVC < 50% and/or FEV1 < 50%)
- Severe chronic kidney disease (Estimated Glomerular Filtration Rate < 15 ml/min and/or proteinuria > 0.5 g/24h)
- Cancer non in remission (necessitating specific treatment) during the past 12 months
- Connective Tissue Disease non in remission (necessitating specific treatment) during the past 12 months - Bone marrow transplantation
- Connective Tissue disease non in remission (necessitating specific treatment) during the past 12months - Immunosuppressive drugs except sirolimus, ongoing or stopped in less than 3 months
- Polyvalent immunoglobulins (IV or sub-cut) ongoing or stopped in less than 3 months
- Any biotherapies (mAbs) such as ant-CD20, CTLA4Ig, anti-TNF, anti-IL6R, anti-IL1 etc… ongoing or stopped in less than 6 months.
- Seropositivity for HIV, HCV or HBV
- Contraindication to muscle MRI
- Contraindications to the liposuction: eg coagulation disorders, etc… - Contraindications to anaesthetics
- Documented conventional antibiotics severe allergy such as ß-lactam (cephalosporin), cyclins, macrolides (for example metronidazole), quinolones
- Participation in another trial (Jardé 1 or Jardé 2)
- Legal protection (curatorship or tutorship) or safety measure