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Status unknownNCT01832428BMACSUpdated Sep 17, 2014

A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cell for the Treatment of Stroke.

A Phase 1/2 interventional study of Intra thecal transplantation of Autologous Stem Cells in Stroke,, sponsored by Chaitanya Hospital, Pune. Status unknown at 1 site in India. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-17.

Sponsored by Chaitanya Hospital, Pune · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Stroke,

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03

In context

Stroke

7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's planned enrollment of 50 is close to the median of 50 across 5,482 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Chaitanya Hospital, Pune is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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,
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Other
    Transfer of autologous MNC intrathecally

    Intra thecal transplantation of autologous stem cells 100 Millions per dose in 3 divided doses at interval of 7days.

    Other: Intra thecal transplantation of Autologous Stem Cells

Interventions

  • OtherIntra thecal transplantation of Autologous Stem Cells

    Intra thecal transplantation of Autologous Stem Cells

06

What researchers measure

Primary outcomes

  1. Improvement in power of Body and facial Muscles

    Improvement in power of Body and facial Muscles.

    Time frame: 6 Months

Secondary outcomes

  1. Improvement in Walking Ability

    Improvement in Walking Ability in 6 month.

    Time frame: 6 months

  2. Improvement In Speech and cognition

    \- Improvement In Speech and cognition ,Time period-6 month

    Time frame: 6 Months

  3. Improvement in Vision in both eyes

    Improvement in Vision in both eyes 6 month

    Time frame: 6 month

07

Study locations

1 of 1 sites recruiting
  • Chaitanya Hospital
    Pune, Maharashtra 411009, India
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2014, a primary completion of Sep 2016 and a completion of Nov 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 9, 2013
First posted
Apr 16, 2013
Start
Sep 2014
Primary completionEst.
Sep 2016
CompletionEst.
Nov 2016
Last update
Sep 17, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01832428
Lead sponsor
Chaitanya Hospital, Pune
Responsible party
Dr. Sachin Jamadar (CO-Investigator, Chaitanya Hospital, Pune) — Principal investigator
First posted
Apr 16, 2013
Start date
Sep 2014
Primary completion
Sep 2016 (estimated)
Completion
Nov 2016 (estimated)
Last update
Sep 17, 2014

Study contacts

Sachin P Jamadar, Dortho
Contact
sac2751982@gmail.com
+918888788880
ANANT E BAGUL, M.S
principal investigator · CHAITANYA HOSPITAL

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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