Clinical trial NCT01834664: Safety and Efficacy of Bone Marrow Derived Autologous Cells Treatment of Cerebral Palsy in Subjects Above 15 Years
Official title: Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Cerebral Palsy in Subjects Above Years (BMACCP) .It is Self Funded (Patients' Own Funding) Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Ataxic Infantile Cerebral Palsy
Keywords: Ataxic Infantile Cerebral Palsy stem cell therapy
Lead sponsor: Chaitanya Hospital, Pune
Sponsor class: OTHER
First posted: 2013-04-18
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This Study is Single arm, Single Centre trial to study the safety and efficacy of bone marrow derived autologous mononuclear cells (100 millions per dose)study enrollment duration 36 months sample size 100 patients should be treated (above 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern.

Detailed description: Cerebral Palsy is commonest cause of Disability in India and south East Asia. This Study is devised to quantify the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose)study enrolment duration 36 months sample size 100 patients should be treated (above 15 years of age) with cerebral palsy, in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern as per as various clinical scales and also changes in the brain.

Eligibility criteria: Inclusion Criteria:

* Subject aged above 15 years with a diagnosis of Cerebral Palsy. Regional Nerve damage as shown by Magnetic Resonance Imaging(MRI)
* Patient suffer from cerebral palsy due to prenatal and postnatal cause,
* Willing to undergoing Bone Marrow derived autologous stem cell therapy.
* Able to Comprehend and give written informed consent form for the study
* willing to come to the hospital for follow up visits as per the protocol requirements

Exclusion Criteria:

* History of meningitis,meningoencephalitis , epilepsy or life threatening allergic or immune -mediated reaction
* Hemodynamically unstable patients
* history of or concurrent autoimmune disease or acute episode if Guillain- barre syndrome
* peripheral Muscular dystrophy

Primary outcomes:
measure: Improvement in muscle rigidity using Ash worth scale
timeFrame: 6 Months
Secondary outcomes:
measure: Improvement in dysregulated phospholipid Metabolism
timeFrame: 6 months
measure: Improvement in walking ability and kinetic gait Pattern
timeFrame: 6 Months
measure: Improvement in overall motor control using oxford scale
timeFrame: 6 Months
measure: Improvement in orbitoFrontal-amygdala circuit and self-regulation of social -emotional behaviour
timeFrame: 6 month
measure: Improvement in motor-linked implicit learning
timeFrame: 6 month
Other outcomes:
Locations:
city: Pune
country: India
facility: Chaitanya Hospital
state: Maharashtra
Study officials:
affiliation: CHAITANYA HOSPITAL
name: ANANT E BAGUL, M.S
role: PRINCIPAL_INVESTIGATOR
References: