Spinal Cord Injury.Phase 1/2SCINCT01833975
Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Spinal Cord Injury
A Phase 1/2 study testing Transplantation of Autologous stem cell [MNCs] . in people with Spinal Cord Injury., run by Chaitanya Hospital, Pune at 1 site in India.
Trial summary
This Study is a single arm,Phase I/II , single centre trial to check active comparing the safety and efficacy of Bone marrow derived autologous cell(100 million per dose) trial to be conducted for 36 months. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury.
- What is being tested?
- Transplantation of Autologous stem cell [MNCs] .
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2014to Sep 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient should suffer from Spinal cord injury.
- 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 Procedures.
- traumatic Injury of spinal cord with complete or partial damage by MRI and Spinal cord injury level should be below C4
Who cannot join
- Patient with pre- existing or current systemic disease such as Lung, liver,(exception:history of uncomplicated hepatitis A)gastrointestinal,cardiac , immunodeficiency(HIV)
- History of life threatening allergic or immune - mediated reaction.
- haemodynamically unstable patients.
- patient suffer from peripheral muscular dystrophy.
- lactating and pregnant woman
- alcohol drug abuse /dependence
- positive test result for hepatitis A and Hepatitis B OR C
- Major-traumatic brain injury and patient with psychiatric illness .
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Chaitanya Hospital
Pune, Maharashtra, 411009
Sachin P Jamadar, D ORTHO, 8888788880, sac2751982@gmail.com
Anant E Bagul, MS
About this study
Official title: Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Spinal Cord Injury . It is Self Funded (Patients' Own Funding) Clinical Trial
This Study is a single arm,Phase I/II , single centre trial to check active comparing the safety and efficacy of Bone marrow derived autologous cell(100 million per dose) trial to be conducted for 36 months.
Read the detailed description
A spinal cord injury (SCI) refers to any injury to the spinal cord that is caused by trauma instead of disease.[1] Depending on where the spinal cord and nerve roots are damaged, the symptoms can vary widely, from pain to paralysis to incontinence.[2][3] Spinal cord injuries are described at various levels of "incomplete", which can vary from having no effect on the patient to a "complete" injury which means a total loss of function.Injuries at any level can cause:Increased muscle tone (spasticity),Loss of normal bowel and bladder control (may include constipation, incontinence, bladder spasms),Numbness,Sensory changes Pain,Weakness, paralysis. This Study is a single arm,Phase I/II , single centre trial to check active comparing the safety and efficacy of Bone marrow derived autologous cell(100 million per dose) trial to be conducted for 36 months.
- Conditions
- Spinal Cord Injury.
- Being tested
- Transplantation of Autologous stem cell [MNCs] .
- Keywords
- Spinal Cord Injury stem cell
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transplantation of Autologous stem cell [MNCs] .Biological
Also called Autologous stem cell[MNCs] .
Intra thecal transplantation of Autologous stem cell [MNCs],100millions per dose in 3 divided doses at interval of 10 days.
| Study group | Role | What they receive |
|---|---|---|
| stem cell [ MNCs ] | Other | transplantation of autologous stem cell [MNCs ] Receives: Biological: Transplantation of Autologous stem cell [MNCs] . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in overall sensory for motor control using Frankel score.
Measured: 6 month
Secondary outcomes (3)
Improvement in pain sensation and Significant changes in Muscle Tones from base line
Measured: 6 month
-Improvement in sensory and motor dysfunction using ASIA( American spinal cord injury association ) Scale
Measured: 6 month
Significant changes in Muscle Tones and Improvement in pain sensation from base line
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 posted17 Apr 2013 (estimated)
- Study startSep 2014
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury.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
- NCT01833975
- Sponsor's protocol ID
- 00103
- Acronym
- SCI
- 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
- Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Spinal Cord Injury . It is Self Funded (Patients' Own Funding) Clinical Trial
- ClinicalTrials.gov ID
- NCT01833975
- Acronym / sponsor ID
- SCI / 00103
- Conditions
- Spinal Cord Injury.
- Keywords
- Spinal Cord Injury stem cell
- 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
- Sep 2016 (estimated)
- First posted
- 17 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 a single arm,Phase I/II , single centre trial to check active comparing the safety and efficacy of Bone marrow derived autologous cell(100 million per dose) trial to be conducted for 36 months.
Detailed description
A spinal cord injury (SCI) refers to any injury to the spinal cord that is caused by trauma instead of disease.[1] Depending on where the spinal cord and nerve roots are damaged, the symptoms can vary widely, from pain to paralysis to incontinence.[2][3] Spinal cord injuries are described at various levels of "incomplete", which can vary from having no effect on the patient to a "complete" injury which means a total loss of function.Injuries at any level can cause:Increased muscle tone (spasticity),Loss of normal bowel and bladder control (may include constipation, incontinence, bladder spasms),Numbness,Sensory changes Pain,Weakness, paralysis. This Study is a single arm,Phase I/II , single centre trial to check active comparing the safety and efficacy of Bone marrow derived autologous cell(100 million per dose) trial to be conducted for 36 months.
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 [ MNCs ] | Other | Biological: Transplantation of Autologous stem cell [MNCs] .transplantation of autologous stem cell [MNCs ] |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient should suffer from Spinal cord injury.
- 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 Procedures.
- traumatic Injury of spinal cord with complete or partial damage by MRI and Spinal cord injury level should be below C4
Key exclusion criteria (8 listed)
- Patient with pre- existing or current systemic disease such as Lung, liver,(exception:history of uncomplicated hepatitis A)gastrointestinal,cardiac , immunodeficiency(HIV)
- History of life threatening allergic or immune - mediated reaction.
- haemodynamically unstable patients.
- patient suffer from peripheral muscular dystrophy.
- lactating and pregnant woman
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 |
|---|---|---|
| Transplantation of Autologous stem cell [MNCs] .Also: Autologous stem cell[MNCs] .Intra thecal transplantation of Autologous stem cell [MNCs],100millions per dose in 3 divided doses at interval of 10 days. | Biological | stem cell [ MNCs ] |
Primary outcome
Improvement in overall sensory for motor control using Frankel score.
Time frame: 6 month
3 secondary outcomes
Improvement in pain sensation and Significant changes in Muscle Tones from base line
Time frame: 6 month
-Improvement in sensory and motor dysfunction using ASIA( American spinal cord injury association ) Scale
Time frame: 6 month
Significant changes in Muscle Tones and Improvement in pain sensation from base line
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.
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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 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 Transplantation of Autologous stem cell [MNCs] . in people with Spinal Cord Injury., 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 8 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 overall sensory for motor control using Frankel score. (time frame: 6 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.