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Inclusion Body Myositis

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

APHP180593

Status

Recruiting

Type

Interventional

Phase

Phase 1

Placebo

No

Accepting

18-75 Years
45 to 80 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended a year ago

What is this trial about?

Inclusion Body Myositis is a slowly but disabling myopathy, the most frequent in patients over 50 years old. No treatments (in particular immunosuppressive) are known to be efficient. Autologous uncultured adipose-derived stromal vascular fraction (ADSVF) is recognized as an easily accessible (by a standard liposuction to obtain adipose tissue, from which ADSVF are isolated by centrifugation), safe and well tolerated source of cells with angiogenic, anti-inflammatory, immunomodulatory and regenerative properties. The purpose of our ADSVF in IBM phase I trial is to evaluate, for the first time in human diseased muscle, first the tolerance of autologous ADSVF cells locally injected in affected forearm muscles and second their capability to repair those muscles. With always the goals of tolerance first and second muscle repair, we will recruit in parallel two groups of IBM patients: the first treated by sirolimus since at least 6 months (but still disabled) and the second currently (for at least 3 months) without specific treatment for inclusion myositis.

What are the participation requirements?

Yes

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.

No

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

Locations

Location

Status

Recruiting