Clinical trials ongoing


ADIPOSE CELL DERIVED REGENRATIVE ENDOTHELIAL ANGIOGENIC MEDICINE (ACELLDREAM2)

The main purpose of this study is to evaluate the efficacy of regenerative therapy with expanded adipose derived stromal/stem cells, administered intramuscularly in patients with critical leg ischemia.

Clinical indication

Critical limb ischemia

Disease area

Cardiology/Vascular

Cell type

ASC

Autologous/allogeneic

Autologous

Route of administration

Intramuscular 

Biomaterial

No

Transgene

No

Activation/differentiation

No

Trial phase

Phase 2

Recruitment target

43

Year trial started

2019

Trial status

Recruiting

Clinical trial ID

NCT03968198

Website

-

   

Principal investigator : Alessandra Bura-Rivière (Toulouse University hospital, France)

ECELLFrance activity : Cell production (ATMP) (Créteil)

ECELLFrance contact :  Hélène Rouard


Efficacy in Alveolar Bone Regeneration With Autologous MSCs and Biomaterial in Comparison to Autologous Bone Grafting (Maxibone)

A randomized controlled clinical multi center trial to assess the efficacy of a combination of autologous mesenchymal stem cells and biomaterial in jaw bone regeneration prior to dental implant placement in comparison to standard autologous bone block grafting.

Clinical indication

Alveolar bone atrophy

Disease area

Muskeletal

Cell type

BM-MSC

Autologous/allogeneic

Autologous

Route of administration

Local

Biomaterial

Yes

Transgene

No

Activation/differentiation

No

Trial phase

Phase 3

Recruitment target

150

Year trial started

2019

Trial status

Recruiting

Clinical trial ID

NCT04297813

Website

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Principal investigator : Kamal Mustafa (University Hospital of Southern Denmark)

ECELLFrance activity : Cell production (ATMP) (Créteil)

ECELLFrance contact :  Hélène Rouard


Systemic injection of HLA mesenchymal stem cells from intra-familial donor for the treatment of Recessive Dystrophic Epidermolysis Bullosa (MESEBDR)

Phase 1/2 pilot clinical trial, to evaluate the safety and preliminary efficacy of the systemic infusion of mesenchymal stem cells derived from bone marrow (BM-MSCs) from a haploidentical donor to improve the healing process and / or the mucocutaneous fragility phenotype associated with recessive dystrophic epidermolysis bullosa .

Clinical indication

Epidermolysis Bullosa

Disease area

Dermatology

Cell type

BM-MSC

Autologous/allogeneic

Autologous

Route of administration

Systemic

Biomaterial

Yes

Transgene

No

Activation/differentiation

No

Trial phase

1/2

Recruitment target

9

Year trial started

2018

Trial status

Active, not recruiting

Clinical trial ID

NCT04153630

Website

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Principal investigator : Instituto de Investigación Hospital Universitario La Paz

EcellFrance activity : Cell production (ATMP) (Clamart)

ECELLFrance contact : Christophe Martinaud


REgenerative therapy of intervertebral disc (RESPINE)

A double blind phase 2b trial of intradiscal injection of bone marrow derived mesenchymal stromal cells in degenerative disc disease unresponsive to conventional therapy 

Clinical indication

Disc Degenerative Disease

Disease area

Musculoskeletal

Cell type

BM-MSC

Autologous/allogeneic

Allogeneic

Route of administration

Local

Biomaterial

Yes

Transgene

No

Activation/differentiation

No

Trial phase

2b

Recruitment target

112

Year trial started

2018

Trial status

Recruiting

Clinical trial ID

NCT03737461

Website

http://www1.chu-montpellier.fr/fr/respine/projet/

   

Principal investigatorChristian Jorgensen (ECELLFrance)

ECELLFrance activity : Biodistribution (Toulouse), immunomonitoring (Montpellier, Rennes), regulatory dossier, coordination (Christian Jorgensen)

ECELLFrance contact : Christian Jorgensen


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

https://www.resstore.eu/

   

Principal investigator: Olivier Detante (ECELLFrance)

ECELLFrance activities : Cell production (ATMP) (Grenoble, Créteil, Clamart), cell potency/QC and biodistribution (Toulouse), patient immunomonitoring (Rennes, Montpellier), coordination (Olivier Detante)

ECELLFrance contact : Olivier Detante


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 to 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

2

Recruitment target

12

Year trial started

2016

Trial status

Recruiting

Clinical trial ID

NCT02814864

Website

-

   

Principal investigator : Mohamad MOHTY (APHP, France)

ECELLFrance activity : Cell production (ATMP), cell potency/QC (Toulouse), patient immunomonitoring (Rennes, Montpellier), coordination (Jean-Jacques Lataillade)

ECELLFrance contact : Christophe Martinaud


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

BM-MSC

Autologous/allogeneic

Autologous

Route of administration

Local

Biomaterial

Yes

Transgene

No

Activation/differentiation

No

Trial phase

3

Recruitment target

108

Year trial started

2014

Trial status

Recruiting

Clinical trial ID

NCT03325504

Website

-

   

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

ECELLFrance activities : Cell production (ATMP) (Toulouse, Créteil), gene modification/transfection (Toulouse), cell potency/QC (Toulouse), patient immunomonitoring (Rennes, Montpellier), coordination (Luc Sensebé)

ECELLFrance contact : Hélène Rouard


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 osteoarthritis 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

2b

Recruitment target

150

Year trial started

2016

Trial status

Recruiting

Clinical trial ID

NCT02838069

Website

http://adipoa2.eu/

   

Principal investigator : Christian Jorgensen (ECELLFrance)

ECELLFrance activities : Cell production (ATMP) (Toulouse, Créteil), cell potency/QC (Toulouse), patient immunomonitoring (Rennes, Montpellier)

ECELLFrance contact :  Christian Jorgensen


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, guided 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

2

Recruitment target

80 (45 treated)

Year trial started

2016

Trial status

Recruiting

Clinical trial ID

NCT02462330

Website

-

   

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

ECELLFrance activity : Cell production (ATMP)

ECELLFrance contact : Hélène Rouard


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

2b

Recruitment target

20

Year trial started

2014

Trial status

Recruiting

Clinical trial ID

NCT02213705

Website

-

   

Principal investigator : Dominique Farges (AP-HP), France

ECELLFrance activities : cell production (ATMP), patient immunomonitoring

ECELLFrance contact : Christian Jorgensen


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

2

Recruitment target

30

Year trial started

2014

Trial status

Recruiting

Clinical trial ID

NCT02065167

Website

-

   

Principal investigator : Pierre Layrolle (Toulouse University Hospital, France)

ECELLFrance activities : Cell production (ATMP), gene modification/transfection, cell potency/QC, patient immunomonitoring, coordination (Luc Sensebé)

ECELLFrance contact : Hélène Rouard