Clinical trial NCT01984814: Stem Cell Therapy for Amyotrophic Lateral Sclerosis
Official title: The Effect of Autologous Bone Marrow Mononuclear Cell Transplantation on the Survival Duration in Amyotrophic Lateral Sclerosis - A Retrospective Control Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Neurogen Brain and Spine Institute
Sponsor class: OTHER
First posted: 2013-11-15
Enrollment: 0
Sex: ALL
Minimum age (years): 26
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The effect of autologous bone marrow mononuclear cells on duration of survival in Amyotrophic Lateral Sclerosis patients.

Detailed description: Survival duration in Amyotrophic Lateral Sclerosis patients who received cellular transplantation was compared to patients who did not receive cellular transplantation. Kaplan-Meier survival analysis was used for this comparison.

Eligibility criteria: Inclusion Criteria:

* Patients with the diagnoses of definite amyotrophic lateral sclerosis.
* Clear information about date of onset of symptoms, documented contact information and follow up information

Exclusion Criteria:

* Patients with diagnoses of Progressive Lateral sclerosis, Progressive bulbar plasy, Progressive spinal muscular atrophy, Progressive muscular atrophy, monomelicamyotrophy or madras motor neuron disease.
* patients with co-morbidities like presence of acute infections such as Human Immunodeficiency Virus/Hepatitis B Virus/Hepatitis C Virus, malignancies, bleeding tendencies, renal failure, severe liver dysfunction and other acute medical conditions such as respiratory infection and pyrexia.

Primary outcomes:
measure: Duration of survival
timeFrame: 56 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Neurogen brain and spine institute
state: Maharashtra
Study officials:
affiliation: Neurogen Brain and Spine Institute
name: Alok K Sharma, MS,MCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chio A, Logroscino G, Traynor BJ, Collins J, Simeone JC, Goldstein LA, White LA. Global epidemiology of amyotrophic lateral sclerosis: a systematic review of the published literature. Neuroepidemiology. 2013;41(2):118-30. doi: 10.1159/000351153. Epub 2013 Jul 11.
citation: Deda H, Inci MC, Kurekci AE, Sav A, Kayihan K, Ozgun E, Ustunsoy GE, Kocabay S. Treatment of amyotrophic lateral sclerosis patients by autologous bone marrow-derived hematopoietic stem cell transplantation: a 1-year follow-up. Cytotherapy. 2009;11(1):18-25. doi: 10.1080/14653240802549470.
citation: Blanquer M, Moraleda JM, Iniesta F, Gomez-Espuch J, Meca-Lallana J, Villaverde R, Perez-Espejo MA, Ruiz-Lopez FJ, Garcia Santos JM, Bleda P, Izura V, Saez M, De Mingo P, Vivancos L, Carles R, Jimenez J, Hernandez J, Guardiola J, Del Rio ST, Antunez C, De la Rosa P, Majado MJ, Sanchez-Salinas A, Lopez J, Martinez-Lage JF, Martinez S. Neurotrophic bone marrow cellular nests prevent spinal motoneuron degeneration in amyotrophic lateral sclerosis patients: a pilot safety study. Stem Cells. 2012 Jun;30(6):1277-85. doi: 10.1002/stem.1080.