Trial record 2 of 15 for:
stem cells AND cerebral palsy
Safety and Efficacy of Bone Marrow Derived Autologous Cells Treatment of Cerebral Palsy in Subjects Above 15 Years (BMACCP)
This study is currently recruiting participants.
Verified April 2013 by Chaitanya Hospital, Pune
Sponsor:
Chaitanya Hospital, Pune
Information provided by (Responsible Party):
Dr. Sachin Jamadar, Chaitanya Hospital, Pune
ClinicalTrials.gov Identifier:
NCT01834664
First received: April 8, 2013
Last updated: April 16, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ataxic Infantile Cerebral Palsy |
Biological: stem cell (MNCs ) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Cerebral Palsy in Subjects Above Years (BMACCP) |
Resource links provided by NLM:
Further study details as provided by Chaitanya Hospital, Pune:
Primary Outcome Measures:
- Improvement in muscle rigidity using Ash worth scale [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Improvement in dysregulated phospholipid Metabolism [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Improvement in walking ability and kinetic gait Pattern [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
- Improvement in overall motor control using oxford scale [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
- Improvement in orbitoFrontal-amygdala circuit and self-regulation of social -emotional behaviour [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
- Improvement in motor-linked implicit learning [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
STEM CELL
Transfer of autologous stem cell [MNCs ]intrathecally
|
Biological: stem cell (MNCs )
Intra thecal transplantation of autologous stem cell [MNCs ]Per dose at the interval
Other Name: Intra thecal autologous stem cell MNCs
|
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| Ages Eligible for Study: | 15 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01834664
Contacts
| Contact: Sachin S Jamadar, Dortho | +918888788880 | sac2751982@gmail.com |
| Contact: Smita S Bhoyar, B.A.M.S.PGCR | 9372620569 | drsmitabhoyar@rediff.com |
Locations
| India | |
| Chaitanya Hospital | Recruiting |
| Pune, Maharashtra, India, 411009 | |
| Contact: Sachin S Jamadar, MBBS.DOrtho 8888788880 sac2751982@gmail.com | |
| Contact: Smita S Bhoyar, BAMSPGCR 9372620569 drsmitabhoyar@rediffmail.com | |
| Principal Investigator: Anant E Bagul, M.S.Ortho | |
Sponsors and Collaborators
Chaitanya Hospital, Pune
Investigators
| Principal Investigator: | ANANT E BAGUL, M.S | CHAITANYA HOSPITAL |
More Information
No publications provided
| Responsible Party: | Dr. Sachin Jamadar, CO-Investigator, Chaitanya Hospital, Pune |
| ClinicalTrials.gov Identifier: | NCT01834664 History of Changes |
| Other Study ID Numbers: | 00109 |
| Study First Received: | April 8, 2013 |
| Last Updated: | April 16, 2013 |
| Health Authority: | India: Institutional Review Board |
Keywords provided by Chaitanya Hospital, Pune:
|
Ataxic Infantile Cerebral Palsy stem cell therapy |
Additional relevant MeSH terms:
|
Cerebral Palsy Paralysis Brain Damage, Chronic Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013