A phase I, prospective, bi-centric, single-arm, open-label, dose-escalating clinical trial to evaluate the safety of a single injection of autologous adipose derived mesenchymal stromal cells in the treatment of severe osteoarthritis of the knee joint (ADIPOA1)

 

This study is designed to determine the safety and efficacy of a single injection of autologous adipose derived mesenchymal stromal cells (ASCs) on patients with severe osteoarthritis of the knee (OA).

 

Clinical indication

Osteoarthritis

Disease area

Musculoskeletal

Cell type

ASC

Autologous/allogeneic

Autologous

Route of administration

Local

Biomaterial

No

Transgene

No

Activation/differentiation

No

Trial phase

I

Recruitment target

18

Year trial started

2012

Trial status

Completed

Clinical trial ID

NCT01585857

Website

-

 

 

 

Principal investigator: Prof Christian Jorgensen (EcellFrance)

EcellFrance activity: cell production (ATMP), coordination (Christian Jorgensen)

EcellFrance contact:  Christian Jorgensen

 

 

 Mesenchymal Stem Cells and Myocardial Ischemia (MESAMI)

This study purpose is to evaluate the safety of injecting MSCs directly into the heart to repair and restore heart function in people who have had a heart attack and who have chronic myocardial ischemia with heart failure.

 

Clinical indication

Chronic Myocardial Ischemia

Disease area

Cardiology/Vascular

Cell type

BMSC

Autologous/allogeneic

Autologous

Route of administration

Local

Biomaterial

No

Transgene

No

Activation/differentiation

No

Trial phase

I

Recruitment target

10

Year trial started

2009

Trial status

Completed

Clinical trial ID

NCT01076920

Website

 

 

 

 

Principal investigator: Dr. Jérome Roncalli (Toulouse University hospital, France)

EcellFrance activity: cell production (ATMP)

EcellFrance contact: Luc Sensebé

 

 

 Evaluation of Efficacy and Safety of Autologous MSCs Combined to Biomaterials to Enhance Bone Healing (OrthoCT1)

The expected results are to obtain bone consolidation thus healing of delayed union or non-union using proposed IMP based on pluripotent MSCs expanded in a GMP facility and mixed with granulated biphasic calcium phosphate in the surgical setting before implantation.

 

Clinical indication

Delayed-union or non-union fractures of long bones

Disease area

Musculoskeletal

Cell type

BMSC

Autologous/allogeneic

Autologous

Route of administration

Local

Biomaterial

Yes

Transgene

No

Activation/differentiation

No

Trial phase

II

Recruitment target

30

Year trial started

2013

Trial status

Completed

Clinical trial ID

NCT01842477

Website

 

 

 

 

Principal investigator: Prof Enrique Gomez-Barrena (Universidad Autonoma de Madrid)

EcellFrance activity: cell production (ATMP), gene modification/transfection, cell potency/QC, patient immunomonitoring, coordination (Luc Sensebé)

EcellFrance contact: Luc Sensebé