Ataxic Infantile Cerebral PalsyPhase 1/2BMACCPNCT01834664
Safety and Efficacy of Bone Marrow Derived Autologous Cells Treatment of Cerebral Palsy in Subjects Above 15 Years
A Phase 1/2 study testing stem cell (MNCs ) in people with Ataxic Infantile Cerebral Palsy, run by Chaitanya Hospital, Pune at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ataxic Infantile Cerebral Palsy
- What is being tested?
- stem cell (MNCs )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2013to Jun 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Chaitanya Hospital
Pune, Maharashtra, 411009
Sachin S Jamadar, MBBS.DOrtho, 8888788880, sac2751982@gmail.com
Anant E Bagul, M.S.Ortho
About this study
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
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.
Read the 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.
- Conditions
- Ataxic Infantile Cerebral Palsy
- Being tested
- stem cell (MNCs )
- Keywords
- Ataxic Infantile Cerebral Palsy stem cell therapy
- Medical subject headings
- Cerebral Palsy, Ataxic, Autosomal Recessive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stem cell (MNCs )Biological
Also called Intra thecal autologous stem cell MNCs
Intra thecal transplantation of autologous stem cell [MNCs ]Per dose at the interval
| Study group | Role | What they receive |
|---|---|---|
| STEM CELL | Other | Transfer of autologous stem cell [MNCs ]intrathecally Receives: Biological: stem cell (MNCs ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in muscle rigidity using Ash worth scale
Measured: 6 Months
Secondary outcomes (5)
Improvement in dysregulated phospholipid Metabolism
Measured: 6 months
Improvement in walking ability and kinetic gait Pattern
Measured: 6 Months
Improvement in overall motor control using oxford scale
Measured: 6 Months
Improvement in orbitoFrontal-amygdala circuit and self-regulation of social -emotional behaviour
Measured: 6 month
Improvement in motor-linked implicit learning
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ataxic Infantile Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chaitanya Hospital, Pune
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sachin Jamadar, Chaitanya Hospital, Pune
- Investigators
- ANANT E BAGUL, M.S, Principal investigator, CHAITANYA HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834664
- Sponsor's protocol ID
- 00109
- Acronym
- BMACCP
- Status last verified
- Sep 2014
- First submitted
- 8 Apr 2013
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01834664
- Acronym / sponsor ID
- BMACCP / 00109
- Conditions
- Ataxic Infantile Cerebral Palsy
- Keywords
- Ataxic Infantile Cerebral Palsy stem cell therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chaitanya Hospital, PuneUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 18 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEM CELL | Other | Biological: stem cell (MNCs )Transfer of autologous stem cell [MNCs ]intrathecally |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stem cell (MNCs )Also: Intra thecal autologous stem cell MNCsIntra thecal transplantation of autologous stem cell [MNCs ]Per dose at the interval | Biological | STEM CELL |
Primary outcome
Improvement in muscle rigidity using Ash worth scale
Time frame: 6 Months
5 secondary outcomes
Improvement in dysregulated phospholipid Metabolism
Time frame: 6 months
Improvement in walking ability and kinetic gait Pattern
Time frame: 6 Months
Improvement in overall motor control using oxford scale
Time frame: 6 Months
Improvement in orbitoFrontal-amygdala circuit and self-regulation of social -emotional behaviour
Time frame: 6 month
Improvement in motor-linked implicit learning
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
Related trials for Ataxic Infantile Cerebral Palsy
Active, not recruiting
Proprioceptive Neuromuscular Facilitation Versus Music Therapy in Ataxic Cerebral Palsy
Cerebral Palsy (CP)
RecruitingObservational study
ARTEMIS - The ARTEMIS Cohort
Non-progressive Congenital Ataxia, Ataxic Cerebral Palsy
Recruiting
Effects of VOJTA Technique on Ataxic Cerebral Palsy.
Ataxic Cerebral Palsy
Active, not recruiting
Efficacy of Adding Lower Extremity Weights on Balance in Children With Ataxic Cerebral Palsy
Ataxic Cerebral Palsy
Recruiting
Effects of Swiss Ball vs Frenkle Exercises on Static and Dynamic Balance in Ataxic CP
Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANANT E BAGUL, M.S principal investigator
CHAITANYA HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing stem cell (MNCs ) in people with Ataxic Infantile Cerebral Palsy, run by Chaitanya Hospital, Pune at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sachin S Jamadar, Dortho (+918888788880, sac2751982@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in muscle rigidity using Ash worth scale (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2014.