Cerebellar AtaxiaPhase 1/2NCT01958177
Clinical Study to Evaluate the Safety and Efficacy BMMNC in Cerebellar Ataxia
A Phase 1/2 study testing Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) in people with Cerebellar Ataxia, run by Chaitanya Hospital, Pune at 1 site in India.
Trial summary
Cerebellar ataxia is a complex motor disturbance, which, can occur as a result of many diseases and presents with symptoms of an inability to coordinate balance, gait, extremity and eye movements. Lesions to the cerebellum can cause dyssynergia, dysmetria, dysdiadochokinesia, dysarthria and ataxia of stance and gait. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebellar Ataxia
- What is being tested?
- Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2014to Dec 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age limit: 18 -65
- Diagnosed as Cerebellar ataxia
- Willingness to undergo Bone marrow transplantation BMMNC.
- To give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.
- willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.
Who cannot join
- 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.
- Women who are pregnant or lactating
- Chronic kidney disease due to autoimmune aetiology, connective tissue disease, amyloidosis and storage disorders.
- Suffering from Severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores.
- Positive test results for HIV and AIDS complex ,HCV , HbsAg and Syphilis
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Chaitanya Hospital
Pune, Maharashtra, 411030
Sachin P Jamadar, D ORTHO, +918888788880, sac2751982@gmail.com
Anant E Bagul, MS,Ortho
About this study
Official title: Clinical Study to Evaluate the Safety and Efficacy of Bone Marrow Derived Mono Nuclear Stem Cell (BMMNCs) in Cerebellar Ataxia .It is Self Funded (Patients' Own Funding) Clinical Trial
Cerebellar ataxia is a complex motor disturbance, which, can occur as a result of many diseases and presents with symptoms of an inability to coordinate balance, gait, extremity and eye movements. Lesions to the cerebellum can cause dyssynergia, dysmetria, dysdiadochokinesia, dysarthria and ataxia of stance and gait. Deficits are observed with movements on the same side of the body as the lesion (ipsilaterally).
- Conditions
- Cerebellar Ataxia
- Being tested
- Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)
- Keywords
- stem cell, cerebellar ataxia, BMMNC
- Medical subject headings
- Cerebellar Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)Biological
Total 3 doses ,in 30 days ,in 7days interval Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell BMMNCs)
| Study group | Role | What they receive |
|---|---|---|
| BMMNC | Other | Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) Receives: Biological: Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
improve in INTERNATIONAL CO-OPERATIVE ATAXIA RATING SCALE
To see improvement in INTERNATIONAL CO-OPERATIVE ATAXIA RATING SCALE when compare with baseline and after 12 month.
Measured: baseline and after 12 month
Secondary outcomes (3)
Balance test
To see improvement in Balance test when compare with baseline and after 12 month.
Measured: baseline and after 12 MONTH
Tremor Rating Scale
compare the pre and post Tremor Rating Scale
Measured: baseline and after 12 MONTH
quality of life
Measured: baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startSep 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebellar AtaxiaStudies 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
- 20 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, MS ORTHO, Principal investigator, Chaitanya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958177
- Sponsor's protocol ID
- CSCC/BMCA/2013//01
- Status last verified
- Sep 2014
- First submitted
- 31 Jul 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
- Clinical Study to Evaluate the Safety and Efficacy of Bone Marrow Derived Mono Nuclear Stem Cell (BMMNCs) in Cerebellar Ataxia .It is Self Funded (Patients' Own Funding) Clinical Trial
- ClinicalTrials.gov ID
- NCT01958177
- Acronym / sponsor ID
- CSCC/BMCA/2013//01
- Conditions
- Cerebellar Ataxia
- Keywords
- stem cell, cerebellar ataxia, BMMNC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chaitanya Hospital, PuneUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Oct 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.
Cerebellar ataxia is a complex motor disturbance, which, can occur as a result of many diseases and presents with symptoms of an inability to coordinate balance, gait, extremity and eye movements. Lesions to the cerebellum can cause dyssynergia, dysmetria, dysdiadochokinesia, dysarthria and ataxia of stance and gait. Deficits are observed with movements on the same side of the body as the lesion (ipsilaterally).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMMNC | Other | Biological: Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age limit: 18 -65
- Diagnosed as Cerebellar ataxia
- Willingness to undergo Bone marrow transplantation BMMNC.
- To give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.
- willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.
Key exclusion criteria (5 listed)
- 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.
- Women who are pregnant or lactating
- Chronic kidney disease due to autoimmune aetiology, connective tissue disease, amyloidosis and storage disorders.
- Suffering from Severe co-morbidities like cardiac insufficiency, congestive cardiac failure, malignancy, infection, sepsis and bed sores.
- Positive test results for HIV and AIDS complex ,HCV , HbsAg and Syphilis
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 |
|---|---|---|
| Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)Total 3 doses ,in 30 days ,in 7days interval Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell BMMNCs) | Biological | BMMNC |
Primary outcome
improve in INTERNATIONAL CO-OPERATIVE ATAXIA RATING SCALE
Time frame: baseline and after 12 month
To see improvement in INTERNATIONAL CO-OPERATIVE ATAXIA RATING SCALE when compare with baseline and after 12 month.
3 secondary outcomes
Balance test
Time frame: baseline and after 12 MONTH
Tremor Rating Scale
Time frame: baseline and after 12 MONTH
quality of life
Time frame: baseline and 12 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, MS ORTHO 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 Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) in people with Cerebellar Ataxia, 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 5 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 P Jamadar, D.Ortho (918888788880, sac2751982@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improve in INTERNATIONAL CO-OPERATIVE ATAXIA RATING SCALE (time frame: baseline and after 12 month). 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.