Cerebral PalsyPhase 2/3BMCP2NCT01832454
Safety and Efficacy of Bone Marrow MNC for the Treatment of Cerebral Palsy in Subjects Below 15 Years
A Phase 2/3 study testing Intra thecal inj of autologous MNC in people with Cerebral Palsy, run by Chaitanya Hospital, Pune at 1 site in India.
Trial summary
This Study is Single arm, Single Centre trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36 months in 100 patients ( below 15 years of age) with cerebral palsy in India. Read more about this study
- Who is it for?
- Ages 3 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Intra thecal inj of autologous MNC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2011to Dec 2015
- Phase
- Phase 2/3
- 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 3 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subject aged above 3 years and below 15 years with a diagnosis of Cerebral Palsy.
- Regional Nerve damage as shown by Magnetic Resonance Imaging(MRI)
- 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,meningoencephalits,epilepsy or life threatening allergic or immune -mediated reaction 2
- Hemodynamically unstable patients
- history of or concurrent autoimmune disease or acute episode if Guillain- barre syndrome
- peripheral Muscular dystropy
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Chaitnany Hospital
Pune, Maharashtra, 411009
Sachin A Jamadar, D ORTHO, +918888788880, sac2751982@gmail.com
Dr, Anant E Bagul, MS
About this study
Official title: Safety and Efficacy of Bone Marrow MNC for the Treatment of Cerebral Palsy in Subjects Below Years. It is Self Funded (Patients' Own Funding) Clinical Trial
This Study is Single arm, Single Centre trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36 months in 100 patients ( below 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
This Study is Single arm, Single Centre trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36 months in 100 patients ( below 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern
- Conditions
- Cerebral Palsy
- Being tested
- Intra thecal inj of autologous MNC
- Keywords
- cerebral palsy stem cells [MNCS]
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra thecal inj of autologous MNCOther
Intra thecal inj of autologous MNC
| Study group | Role | What they receive |
|---|---|---|
| Intra thecal inj of autologous MNC | Other | Intra thecal inj of autologous MNC Receives: Other: Intra thecal inj of autologous MNC |
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 and overall motor control using oxford scale.
- Improvement in muscle rigidity using Ash worth scale and overall motor control using oxford scale at Time point - 6 Months.
Measured: 6 months
Secondary outcomes (1)
-Improvement in IQ by using Benit Kamat scale.
-Improvement in IQ by using Benit Kamat scale. Improvement in social behaviour. Reduction in deformity.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startMar 2011
- Primary completionNov 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- 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 stem cell centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832454
- Sponsor's protocol ID
- 00160
- Acronym
- BMCP2
- Status last verified
- Sep 2014
- First submitted
- 26 Feb 2013
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
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 MNC for the Treatment of Cerebral Palsy in Subjects Below Years. It is Self Funded (Patients' Own Funding) Clinical Trial
- ClinicalTrials.gov ID
- NCT01832454
- Acronym / sponsor ID
- BMCP2 / 00160
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy stem cells [MNCS]
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chaitanya Hospital, PuneUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 16 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 trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36 months in 100 patients ( below 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern.
Detailed description
This Study is Single arm, Single Centre trail to check the safety and efficacy of bone marrow derived autologous mononuclear cells(100 millions per dose )trial to be conducted for 36 months in 100 patients ( below 15 years of age) with cerebral palsy in India. Primary outcome measures are improvement in walking ability and kinetic gait pattern
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra thecal inj of autologous MNC | Other | Other: Intra thecal inj of autologous MNCIntra thecal inj of autologous MNC |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subject aged above 3 years and below 15 years with a diagnosis of Cerebral Palsy.
- Regional Nerve damage as shown by Magnetic Resonance Imaging(MRI)
- 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,meningoencephalits,epilepsy or life threatening allergic or immune -mediated reaction 2
- Hemodynamically unstable patients
- history of or concurrent autoimmune disease or acute episode if Guillain- barre syndrome
- peripheral Muscular dystropy
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 |
|---|---|---|
| Intra thecal inj of autologous MNCIntra thecal inj of autologous MNC | Other | Intra thecal inj of autologous MNC |
Primary outcome
Improvement in muscle rigidity using Ash worth scale and overall motor control using oxford scale.
Time frame: 6 months
- Improvement in muscle rigidity using Ash worth scale and overall motor control using oxford scale at Time point - 6 Months.
1 secondary outcome
-Improvement in IQ by using Benit Kamat scale.
Time frame: 6 Months
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.
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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 stem cell centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intra thecal inj of autologous MNC in people with 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 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in muscle rigidity using Ash worth scale and overall motor control using oxford 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.