DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
2	筋萎縮性側索硬化症	1

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2011-006254-85-ES (EUCTR)	08/02/2013	09/08/2012	Clinical trial to value the safety and efficacy of administration of stem cells derived from own patient for the treatment of Amyotrophic Lateral Sclerosis (ALS).	Placebo controlled, randomized and triple blind multicentric phase I/II clinical trial to evaluate the safety, feasibility and valoration of efficacy trends of intravenous administration of three doses of autologous adipose derived autologous mesenchymal stem cells (CeTMAd) in moderate/severe ALS patients.	Amyotrophic lateral sclerosis (ALS) MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Células madre mesenquimales de tejido adiposo autólogo INN or Proposed INN: NA Other descriptive name: Células Mesenquimales de tejido adiposo	FUNDACIÓN PROGRESO Y SALUD	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 1;Phase 2	Spain

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2011-006254-85-ES
(EUCTR)

08/02/2013

09/08/2012

Clinical trial to value the safety and efficacy of administration of stem cells derived from own patient for the treatment of Amyotrophic Lateral Sclerosis (ALS).

Placebo controlled, randomized and triple blind multicentric phase I/II clinical trial to evaluate the safety, feasibility and valoration of efficacy trends of intravenous administration of three doses of autologous adipose derived autologous mesenchymal stem cells (CeTMAd) in moderate/severe ALS patients.

Amyotrophic lateral sclerosis (ALS)
MedDRA version: 14.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Células madre mesenquimales de tejido adiposo autólogo
INN or Proposed INN: NA
Other descriptive name: Células Mesenquimales de tejido adiposo

FUNDACIÓN PROGRESO Y SALUD

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Phase 1;Phase 2

Spain