Stroke,Phase 1/2BMACSNCT01832428
A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cell for the Treatment of Stroke.
A Phase 1/2 study testing Intra thecal transplantation of Autologous Stem Cells in people with Stroke,, run by Chaitanya Hospital, Pune at 1 site in India.
Trial summary
This study is single, centre trial to study the safety and efficacy of Bone marrow derived autologous MNCS(100 million per dose)trial to be conducted for 36 months in stroke patients , the primary outcome measure will be the improvement in muscle power of Body and face Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke,
- What is being tested?
- Intra thecal transplantation of Autologous Stem Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2014to Nov 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient should suffer from stroke due to cerebral infarct or Haemorrhage or accelerated hypertension.
- willingness to undergo bone marrow derived autologous cell therapy.
- patient those provide fully Informed consent form for the study.
- Ability and willingness to regular visit to hospital and follow up during the protocol Procedure.
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 laboratory Investigation that could cause a neurological defect.History of Life threating Allergic or immune- mediated reaction.
- Alcohol and drug abuse / dependence.
- Severe skin infection.
- Haemodynamically unstable.
- subject with primary and secondary diabetes , Insulin depenence,
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Chaitanya Hospital
Pune, Maharashtra, 411009
Sachin P Jamadar, Dortho, +918888788880, sac2751982@gmail.com
Smita S Bhoyar, BAMS PGCR, +9372620569, drsmitabhoyar@rediffmail.com
About this study
Official title: A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cell for the Treatment of Stroke. It is Self Funded (Patients' Own Funding) Clinical Trial
This study is single, centre trial to study the safety and efficacy of Bone marrow derived autologous MNCS(100 million per dose)trial to be conducted for 36 months in stroke patients , the primary outcome measure will be the improvement in muscle power of Body and face
Read the detailed description
This study is single centre trial to study the safety and efficacy of Bone marrow derived autologous MNCS(100 million per dose)trial to be conducted for 36 months in stroke patients , the primary outcome measure will be the improvement in muscle power of Body and face
- Conditions
- Stroke,
- Being tested
- Intra thecal transplantation of Autologous Stem Cells
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra thecal transplantation of Autologous Stem CellsOther
Intra thecal transplantation of Autologous Stem Cells
| Study group | Role | What they receive |
|---|---|---|
| Transfer of autologous MNC intrathecally | Other | Intra thecal transplantation of autologous stem cells 100 Millions per dose in 3 divided doses at interval of 7days. Receives: Other: Intra thecal transplantation of Autologous Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in power of Body and facial Muscles
Improvement in power of Body and facial Muscles.
Measured: 6 Months
Secondary outcomes (3)
Improvement in Walking Ability
Improvement in Walking Ability in 6 month.
Measured: 6 months
Improvement In Speech and cognition
- Improvement In Speech and cognition ,Time period-6 month
Measured: 6 Months
Improvement in Vision in both eyes
Improvement in Vision in both eyes 6 month
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 posted16 Apr 2013 (estimated)
- Study startSep 2014
- Primary completionSep 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke,Studies 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
- 50 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
- NCT01832428
- Sponsor's protocol ID
- 00107
- Acronym
- BMACS
- Status last verified
- Sep 2014
- First submitted
- 9 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
- A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cell for the Treatment of Stroke. It is Self Funded (Patients' Own Funding) Clinical Trial
- ClinicalTrials.gov ID
- NCT01832428
- Acronym / sponsor ID
- BMACS / 00107
- Conditions
- Stroke,
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chaitanya Hospital, PuneUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Nov 2016 (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, centre trial to study the safety and efficacy of Bone marrow derived autologous MNCS(100 million per dose)trial to be conducted for 36 months in stroke patients , the primary outcome measure will be the improvement in muscle power of Body and face
Detailed description
This study is single centre trial to study the safety and efficacy of Bone marrow derived autologous MNCS(100 million per dose)trial to be conducted for 36 months in stroke patients , the primary outcome measure will be the improvement in muscle power of Body and face
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transfer of autologous MNC intrathecally | Other | Other: Intra thecal transplantation of Autologous Stem CellsIntra thecal transplantation of autologous stem cells 100 Millions per dose in 3 divided doses at interval of 7days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient should suffer from stroke due to cerebral infarct or Haemorrhage or accelerated hypertension.
- willingness to undergo bone marrow derived autologous cell therapy.
- patient those provide fully Informed consent form for the study.
- Ability and willingness to regular visit to hospital and follow up during the protocol Procedure.
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 laboratory Investigation that could cause a neurological defect.History of Life threating Allergic or immune- mediated reaction.
- Alcohol and drug abuse / dependence.
- Severe skin infection.
- Haemodynamically unstable.
- subject with primary and secondary diabetes , Insulin depenence,
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 transplantation of Autologous Stem CellsIntra thecal transplantation of Autologous Stem Cells | Other | Transfer of autologous MNC intrathecally |
Primary outcome
Improvement in power of Body and facial Muscles
Time frame: 6 Months
Improvement in power of Body and facial Muscles.
3 secondary outcomes
Improvement in Walking Ability
Time frame: 6 months
Improvement In Speech and cognition
Time frame: 6 Months
Improvement in Vision in both eyes
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 Stroke,
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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 Intra thecal transplantation of Autologous Stem Cells in people with Stroke,, 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 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, 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 power of Body and facial Muscles (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.