CClinicalTrials.gg
Status unknownNCT01834040BMMNCUpdated Sep 17, 2014

Study Safety and Efficacy of BMMNC for the Patient With Duchenne Muscular Dystrophy

A Phase 1/2 interventional study of Intralesional/ Intravenous of Autologous Stem cells. in Muscular Dystrophy and Duchenne Muscular Dystrophy, sponsored by Chaitanya Hospital, Pune. Status unknown at 1 site in India. Open to participants aged 4 Years to 20 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has not verified this record recently (last verified Sep 2014), so the status shown — last known as Recruiting — may be out of date.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
30
Allocation
Not applicable
Ages
4 Years to 20 Years
Sex
All
01

Study summary

This Study is single arm, single center trial to check the safety and efficacy of BMMNC (100 million per dose) for the patient with Duchenne Muscular Dystrophy,

Read the detailed description

Muscular dystrophies, or MD, are a group of inherited conditions, which means they are passed down through families. They may occur in childhood or adulthood. There are many different types of muscular dystrophy. They include:

Duchenne muscular dystrophy is a form of muscular dystrophy that worsens quickly. Other muscular dystrophy (including Becker's muscular dystrophy) get worse much more slowly.

Duchenne muscular dystrophy is caused by a defective gene for dystrophin (a protein in the muscles). However, it often occurs in people without a known family history of the condition.

Symptoms usually appear before age 6 and may appear as early as infancy. They may include:

Fatigue

Learning difficulties (the IQ (intelligence quotient )can be below 75)

Intellectual disability (possible, but does not get worse over time)

Muscle weakness

Begins in the legs and pelvis, but also occurs less severely in the arms, neck, and other areas of the body

Difficulty with motor skills (running, hopping, jumping)

Frequent falls

Trouble getting up from a lying position or climbing stairs

Weakness quickly gets worse

Progressive difficulty walking

Ability to walk may be lost by age 12, and the child will have to use a wheelchair

Breathing difficulties and heart disease usually start by age 20

02

Conditions studied

  • Muscular Dystrophy
  • Duchenne Muscular Dystrophy

Keywords

  • Duchenne Muscular Dystrophy
  • Muscular Dystrophy
  • Myopathy
03

In context

Muscular Dystrophies

548 studies on the registry are indexed under Muscular Dystrophies; 89 are open to participants now.

This study's planned enrollment of 30 is above the median of 24 across 344 interventional studies indexed under Muscular Dystrophies.

Browse Muscular Dystrophies studies →

Lead sponsor

Chaitanya Hospital, Pune is the lead sponsor of 14 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
4 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patient with Diagnose of Duchenne Muscular Dystrophy.
  • Aged in between 4 to 20 Years.
  • Willingness to undergo Bone Marrow derived Autologous cell Therapy.
  • Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent form(ICF) for the study.
  • Ability and willingness to regular visit to hospital for protocol procedures and follow up

Exclusion criteria

Exclusion Criteria:

  • Patient with History of Immunodeficiency HIV+,Hepatitis B ,HBV and TPPA+, Tumor Markers+
  • Patients with History of Hypertension and Hypersensitive.
  • Patient who is not Diagnose of Duchenne Muscular Dystrophy.
  • Alcohol and drug abuse / dependence.
05

Study design

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

Study arms

  • Other
    intralesional and Intravenous

    Intralesional/ Intravenous of Autologous Stem cells.

    Other: Intralesional/ Intravenous of Autologous Stem cells.

Interventions

  • OtherIntralesional/ Intravenous of Autologous Stem cells.

    Intralesional/ Intravenous of Autologous MNCs per dose

    Also known as: Intralesional/ Intravenous of Autologous MNCs., Intralesional/ Intravenous of Autologous MNCs

06

What researchers measure

Primary outcomes

  1. Improvement of daily living scale.

    Time frame: 6 MONTH

Secondary outcomes

  1. Improvement of Muscular dystrophy specific functional Rating scale

    Time frame: 6 Months

07

Study locations

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

Updates

Tracking since Sep 25, 2026
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
NCT01834040
Lead sponsor
Chaitanya Hospital, Pune
Responsible party
Dr. Sachin Jamadar (CO-Investigator, Chaitanya Hospital, Pune) — Principal investigator
First posted
Apr 17, 2013
Start date
Sep 2014
Primary completion
Sep 2016 (estimated)
Completion
Oct 2016 (estimated)
Last update
Sep 17, 2014

Study contacts

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

Oversight

Data monitoring committee
Yes
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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion