Clinical trial of autologous adipose-derived mesenchymal stromal cells (ASC) in the treatment of mild to moderate osteoarthritis. (ADIPOA2)

The objective of the study is to conduct a prospective, multicenter single blinded, placebo controlled Phase II study, comparing culture-expanded, autologous adult adipose-MSCs in subjects with knee OA unresponsive to conservative therapy for at least 12 months.

 

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

IIb

Recruitment target

150

Year trial started

2016

Trial status

Recruiting

Clinical trial ID

NCT02838069

Website

http://adipoa2.eu/

 

 

 

Principal investigator: Prof. Christian Jorgensen (EcellFrance)

EcellFrance activity: cell production (ATMP), cell potency/QC, patient immunomonitoring

ECELLFRANCE contact:  Christian Jorgensen

 

 

Intravenous stem cell therapy for ischemic stroke (ISIS)

The main objective of the study is to evaluate feasibility and tolerance of the intravenous injection of autologous mesenchymal stem cells for patients presenting an ischemic stroke.

 

Clinical indication

Stroke

Disease area

Neurology

Cell type

BMSC

Autologous/allogeneic

Autologous

Route of administration

Systemic

Biomaterial

No

Transgene

No

Activation/differentiation

No

Trial phase

IIb

Recruitment target

31

Year trial started

2012

Trial status

Active, not recruiting

Clinical trial ID

NCT00875654

Website

-

 

 

 

Principal investigator: Dr. Olivier Detante (EcellFrance)

EcellFrance activity: cell production (ATMP), coordination (Olivier Detante)

EcellFrance contact: Olivier Detante

 

 

Bone Marrow-derived Mesenchymal Stem Cells (MSC) Administration in Weaning From Left Ventricular Assist Device (MESAD)

Left Ventricular Assist Devices are commonly used to assist failing hearts as a bridge to transplantation or for long-term support. The purpose of the MESenchymal stem cell therapy and Left Ventricular Assist Device program is to improve heart function with stem cell therapy and attempt to wean patients from HeartMate Left Ventricular Assist Device.

 

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

4

Year trial started

2014

Trial status

recruiting

Clinical trial ID

NCT02460770

Website

-

 

 

 

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

EcellFrance activity: cell production (ATMP), regulatory dossier, coordination (Luc Sensebé)

ECELLFRANCE contact: Luc Sensebé

 

 

 Administration of Mesenchymal Stem Cells in Patients With Chronic Ischemic Cardiomyopathy (MESAMI2)

Investigators initiated the MESAMI program by the bicentric pilot phase and highlighted the safety and feasibility of intramyocardial injections of MSCs from bone marrow in patients with chronic ischemic cardiomyopathy and left ventricular dysfunction, guide by the NOGA-XP system. The MESAMI program continues with the phase 2, multicenter, double-blind, randomized, placebo-controlled trial.The aim of this phase 2 study is to demonstrate a functional improvement, measuring peak VO2, at 3 months between the cell therapy group and the placebo group.

 

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

II

Recruitment target

80 (45 treated)

Year trial started

2016

Trial status

Recruiting

Clinical trial ID

NCT02462330

Website

 

 

 

 

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

EcellFrance activity: cell production (ATMP)

EcellFrance contact: Luc Sensebé

 

 

Evaluation of Mesenchymal Stem Cells to Treat Avascular Necrosis of the Hip (ORTHO-2)

The aim of the study is to assess the safety and feasibility of an in situ single injection of a high dose of autologous bone marrow-derived, in vitro expanded Mesenchymal stem cells, and its contribution to the resolution of the early stages of avascular osteonecrosis of the femoral head

 

Clinical indication

Avascular Necrosis of the Femoral Head

Disease area

Musculoskeletal

Cell type

BMSC

Autologous/allogeneic

Autologous

Route of administration

Local

Biomaterial

No

Transgene

No

Activation/differentiation

No

Trial phase

II

Recruitment target

30

Year trial started

2014

Trial status

Recruiting

Clinical trial ID

NCT02065167

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

 

 

 

 ORTHOpedic randomized clinical trial with expanded bone marrow MSC and bioceramics versus autograft in long bone nonUNIONs (ORTHOUNION)

This clinical trial involves two comparative analyses:

  • Comparison of efficacy in terms of superiority of hBM-MSCs + biomaterial (both experimental arms, low and high doses) versus iliac crest autologous graft (active comparator arm).
  • Comparison of efficacy in terms of non-inferiority of low dose hBM-MSC+biomaterial versus high dose of hBM-MSC+biomaterial.

 

Clinical indication

Long bone nonUNIONs

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

2014

Trial status

Recruiting

Clinical trial ID

NCT02065167

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

 

 

 Trial Evaluating the Efficacy of Systemic Mesenchymal Stromal Cell (MSC) Injections for the Treatment of Severe and Chronic Radiotherapy-induced Abdomino-pelvic Complications (Pelvic Radiation Disease, PRD) Refractory to Standard Therapy (PRISME)

The aim of the study is evaluate the efficacy of systemic mesenchymal stromal cell (MSC) injections for the treatment of severe and chronic radiotherapy-induced abdomino-pelvic complications

 

Clinical indication

Pelvic radiation disease

Disease area

Dermatology

Cell type

BMSC

Autologous/allogeneic

Allogeneic

Route of administration

Systemic

Biomaterial

No

Transgene

No

Activation/differentiation

No

Trial phase

II

Recruitment target

12

Year trial started

2016

Trial status

In progress

Clinical trial ID

NCT02814864

Website

 

 

 

 

Principal investigator: Dr Mohamad MOHTY (APHP, France)

EcellFrance activity: cell production (ATMP), gene modification/transfection, cell potency/QC, patient immunomonitoring, coordination (Jean-Jacques Lataillade)

EcellFrance contact: Jean-Jacques Lataillade

 

 

 Regenerative Stem Cell Therapy for Stroke in Europe (RESSTORE)

The study purpose is to explore the efficacy (functional recovery) and safety of intravenous infusion of allogenic adipose tissue derived mesenchymal stem cells (ADSC) in 400 stroke patients. Therapeutic effects of ADSCs will be assessed and monitored in patients using clinical rating scales, multimodal MRI and blood biomarkers.

 

Clinical indication

Stroke

Disease area

Neurology

Cell type

ASC

Autologous/allogeneic

Allogeneic

Route of administration

Systemic

Biomaterial

No

Transgene

No

Activation/differentiation

No

Trial phase

IIb

Recruitment target

400 (200 treated)

Year trial started

2016

Trial status

Recruiting

Clinical trial ID

NCT02849613

Website

http://www.resstore.eu

 

 

 

Principal investigator: Dr Olivier Detante (EcellFrance)

EcellFrance activity: cell production (ATMP), cell potency/QC, patient immunomonitoring, biodistribution, coordination (Olivier Detante)

EcellFrance contact: Olivier Detante

 

 

 Treatment of Refractory Sever Systemic Scleroderma by Injection of Allogeneic Mesenchymal Stem Cells (MSC)

 The main ailm of this phase I-II study is to evaluate toxicity and efficacy of allogenic mesenchymal stem cell therapy to treat severe systemic sclerosis. In practice this treatment will be given to patients with a rapidly evolutive disease or refractory to cyclophosphamide

 

Clinical indication

Scleroderma

Disease area

Immunology

Cell type

BMSC

Autologous/allogeneic

Allogeneic

Route of administration

Systemic

Biomaterial

No

Transgene

No

Activation/differentiation

No

Trial phase

IIb

Recruitment target

20

Year trial started

2014

Trial status

Recruiting

Clinical trial ID

NCT02213705

Website

 

 

 

 

Principal investigator: Prof Dominique Farges (APHP, France)

EcellFrance activity: cell production (ATMP), patient immunomonitoring

EcellFrance contact: Christian Jorgensen