Chaitanya hospitalRahi sakha apartment133 sinhgad road parvati pune Chaitanya hospitalRahi sakha apartment133 sinhgad road parvati pune Pune MAHARASHTRA 411009 India
Chaitanya Vaidyakeeya Seva Sanstha, 44/2 Hill View Society, Paud Phata, Paud Road, Pune 411029,M.S. , INDIA (Its A Registered Charitable Trust Organisation, Which Funds Various Social And Medical Activities)
Should suffer from Acute Paraplegia due to pyramidal or extra-pyramidal cause.
Willingness to undergo Bone marrow derived autologous cell therapy
Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.
Ability and willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.
ExclusionCriteria
Details
Patients with pre-existing or current systemic disease such as lung , liver (exception: history of uncomplicated hepatitis A) gastrointestinal , cardiac, immunodeficiency (including HIV) or any other condition determined by history or laboratory investigation that could cause a neurological defect (including syphilis, clinically relevant polyneuropathy) etc.
History of life threatening allergic or immune-mediated reaction.
Haemodynamically unstable subjects.
Subjects suffering from peripheral muscular dystrophy.
Severe skin infection and osteomyelitis/ or at the site of bone marrow aspiration potentially limiting the procedure.
Positive test results for Hepatitis A and Hepatitis B or C.
Alcohol and / or drug abuse/ dependence.
Subjects with primary or secondary diabetes, insulin dependence or with serum creatinine > 1.5 mg/dL.
Neurological disease caused by autoimmune or genetic cause
Improvement in overall sensory for motor control using Frankel score. Improvement in sensory and motor dysfunction using ASIA scale (American spinal cord injury association
This study is a single arm, single center trial to check the safety and efficacy of bone marrow derived autologous mononuclear cells (100 million per dose) Trial to be conducted for 36 months in 100 patients with Acute Paraplegia, primary outcome measures include Improvement in overall sensory for motor control using Frankel score.
CTRI Number
CTRI/2013/10/004109 [Registered on: 29/10/2013] Trial Registered Retrospectively
Chaitanya Vaidyakeeya Seva Sanstha, 44/2 Hill View Society, Paud Phata, Paud Road, Pune 411029,M.S. , INDIA (Its A Registered Charitable Trust Organisation, Which Funds Various Social And Medical Activities)
Should suffer from Chronic Paraplegia due to pyramidal or extra-pyramidal cause.
Willingness to undergo Bone marrow derived Autologous cell therapy.
Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.
Ability and willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.
ExclusionCriteria
Details
Patients with pre-existing or current systemic disease such as lung , liver (exception: history of uncomplicated hepatitis A) gastrointestinal , cardiac, immunodeficiency (including HIV) or any other condition determined by history or laboratory investigation that could cause a neurological defect (including syphilis, clinically relevant polyneuropathy) etc.
History of life threatening allergic or immune-mediated reaction.
Haemodynamically unstable subjects.
Subjects suffering from peripheral muscular dystrophy.
Severe skin infection and osteomyelitis/ or at the site of bone marrow aspiration potentially limiting the procedure.
Positive test results for Hepatitis A and Hepatitis B or C.
Alcohol and / or drug abuse/ dependence.
Subjects with primary or secondary diabetes, insulin dependence or with serum creatinine > 1.5 mg/dL.
Neurological disease caused by autoimmune or genetic cause.
Improvement in overall sensory for motor control using Frankel score. - Improvement in sensory and motor dysfunction using ASIA scale (American spinal cord injury association)
This study is a single arm, single center trial to check active comparing the safety and efficacy of Bone marrow derived autologous cells (100 million per dose). Trial to be conducted for 36 months in 100 patients with Chronic Paraplegia in India. Primary outcome measures are Improvement in overall sensory for motor control using Frankel score.
A clinical trial to study the safety and efficacy of Bone marrow derived Autologous cells for the treatment of cerebral palsy in subjects above 15 years.
A clinical trial to study the safety and efficacy of Bone marrow derived Autologous stem cells for the treatment of cerebral palsy in subjects above 15 years.
1. Should suffer from cerebral palsy due to prenatal and postnatal cause.
2. Willingness to undergoing Bone marrow derived autologous stem cell therapy
3. Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.
4. Ability and willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.
ExclusionCriteria
Details
1. Patients with pre-existing or current systemic disease such as lung , liver (exception: history of uncomplicated hepatitis A) gastrointestinal , cardiac, immunodeficiency (including HIV) or any other condition determined by history or laboratory investigation that could cause a neurological defect (including syphilis, clinically relevant polyneuropathy) etc.
2. History of life threatening allergic or immune-mediated reaction.
3. Haemodynamically unstable subjects.
4. Subjects suffering from peripheral muscular dystrophy.
5. Severe skin infection and osteomyelitis/ or at the site of bone marrow aspiration potentially limiting the procedure.
6. Positive test results for Hepatitis A and Hepatitis B or C.
7. Alcohol and / or drug abuse/ dependence.
8. Subjects with primary or secondary diabetes, insulin dependence or with serum creatinine > 1.5 mg/dL.
9. Neurological disease caused by autoimmune or genetic cause
Improvement in muscle rigidity using Ashworth scale. - Improvement in walking ability and kinetic gait pattern - Improvement in overall motor control using oxford scale 3 months
Improvement in dysregulated phospholipid metabolism. - Improvement in orbito-frontal-amygdala circuit and self-regulation of social-emotional behavior.. - Improvement in motor-linked implicit learning. - Reduction in burden on family
This study is a single arm, single center trial to check safety and efficacy of Bone marrow derived autologous cells (100 million per dose) . Trial to be conducted for 36 months in 100 Patients. Primary outcome measures are Improvement in walking ability and kinetic gait pattern.
CTRI Number
CTRI/2013/10/004098 [Registered on: 25/10/2013] Trial Registered Prospectively
A clinical trial to study the safety and efficacy of Bone marrow derived Autologous cells for the treatment of cerebral palsy in subjects below 15 years.
A clinical trial to study the safety and efficacy of Bone marrow derived Autologous cells for the treatment of cerebral palsy in subjects below 15 years.
Chaitanya Vaidyakeeya Seva Sanstha, 44/2 Hill View Society, Paud Phata, Paud Road, Pune 411029,M.S. , INDIA
(Its A Registered Charitable Trust Organisation, Which Funds Various Social And Medical Activities)
1. Subjects aged above 3 years and below 15 years with a diagnosis of Cerebral Palsy.
2. Regional nerve damage as shown by Magnetic Resonance Imaging (MRI)
3. Able to comprehend and give informed consent for the study and willing to come to the hospital for follow up visits as per the protocol requirements (patient or his legal guardian).
ExclusionCriteria
Details
1. History of meningitis, meningoencephalitis, epilepsy or life ?threatening allergic or immune-mediated reaction
2. Hemodynamically unstable patients
3. History of or concurrent autoimmune disease or an acute episode of Guillain-barre syndrome
4. Peripheral muscular dystrophy
Improvement in muscle rigidity using Ashworth scale. - Improvement in walking ability and kinetic gait pattern - Improvement in overall motor control using oxford scale. 3 months
This study is a single arm, single center trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells (100 million per dose) Trial to be conducted for 36 months in 100 patients (below 15 yrs of age) with cerebral palsy in India. Primary outcome measures are Improvement in walking ability and kinetic gait pattern.
CTRI Number
CTRI/2013/10/004105 [Registered on: 28/10/2013] Trial Registered Prospectively
Chaitanya Vaidyakeeya Seva Sanstha, 44/2 Hill View Society, Paud Phata, Paud Road, Pune 411029,M.S. , INDIA (Its A Registered Charitable Trust Organisation, Which Funds Various Social And Medical Activities)
1.Should suffer from stroke due to cerebral infarct or haemorrhage or accelerated hyper tension.
2.Willingness to undergo Autologous Stem Cell Therapy
3.Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.
4.Ability and willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.
ExclusionCriteria
Details
1.Patients with pre-existing or current systemic disease such as lung , liver (exception: history of uncomplicated hepatitis A) gastrointestinal , cardiac, immunodeficiency (including HIV) or any other condition determined by history or laboratory investigation that could cause a neurological defect (including syphilis, clinically relevant polyneuropathy) etc.
2.History of life threatening allergic or immune-mediated reaction.
3. Haemodynamically unstable subjects.
4.Subjects suffering from peripheral muscular dystrophy.
5.Severe skin infection and osteomyelitis/ or at the site of bone marrow aspiration potentially limiting the procedure.
6.Positive test results for Hepatitis A and Hepatitis B or C.
7.Alcohol and / or drug abuse/ dependence.
8.Subjects with primary or secondary diabetes, insulin dependence or with serum creatinine > 1.5 mg/dL.
9.Neurological disease caused by autoimmune or genetic cause.
This study is a single arm , single center trail for check the safety and efficacy of bone marrow derived autologous mononuclear cells (100 million per dose) Trial to be conducted for 36 months in 100 stroke Patients The Primary outcome measure will be Improvement in muscle power of Body and face