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Status unknownNCT01914913Updated Sep 17, 2014

Clinical Study to Evaluate Safety and Efficacy of BMMNC in Retinitis Pigmentosa

A Phase 1/2 interventional study of BMMNCs in Retinitis Pigmentosa, sponsored by Chaitanya Hospital, Pune. Status unknown at 1 site in India. Open to participants aged 18 Years to 65 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has not verified this record recently (last verified Sep 2014), so the status shown — last known as Recruiting — may be out of date.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
15
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Retinitis pigmentosa is an eye disease in which there is damage to the retina. The retina is the layer of tissue at the back of the inner eye that converts light images to nerve signals and sends them to the brain.Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) is used for this condition .

Read the detailed description

This study will involve about 8 visits over 1½ years .Each participant will be enrolled in study as per inclusion and exclusion criteria .Informed consent will be taken from subject before including in study. Subject will be underwent for specific tests of the participant's vision and health. These visits may include visual exams, blood draw for laboratory testing, brief medical history and exam, and occasionally a questionnaire (survey), in addition to the visit for the surgical procedures. The primary outcome for this study will be a visual acuity score after one year of stem cell therapy .

Follow-up visits will be required regularly to determine the effectiveness of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs) in RP.

02

Conditions studied

  • Retinitis Pigmentosa

Keywords

  • retinitis pigmentosa
  • Bone marrow
  • stem cell
  • BMMNC
03

In context

Retinitis

250 studies on the registry are indexed under Retinitis; 28 are open to participants now.

This study's planned enrollment of 15 is below the median of 31 across 158 interventional studies indexed under Retinitis.

Browse Retinitis 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
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 18-65
  • Diagnosis of retinitis pigmentosa
  • willingness to undergo Bone marrow and umbilical cord derived Mesenchymal stem cell transplantation.
  • 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.

Exclusion criteria

Exclusion Criteria:

  • Positive test results for HIV and AIDS complex ,HCV (hepatitis C virus ), HbsAg and Syphilis
  • Women who are pregnant or lactating
  • Complications of diabetic retinopathy.
05

Study design

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

Study arms

  • Other
    BMMNCs

    BMMNCs

    Biological: BMMNCs

Interventions

  • BiologicalBMMNCs

    Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval ,transfer of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)

06

What researchers measure

Primary outcomes

  1. visual acuity

    Electronic Visual Acuity (EVA) technology

    Time frame: 1 YEAR

07

Study locations

1 of 1 sites recruiting
  • Chaitanya Hospital
    Pune,, Maharashtra 411030, India
    • Sachin P Jamadar, D ORTHO · Contact · sac2751982@gmail.com · +918888788880
    • Anant E Bagul, MS,Ortho · Principal investigator
    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
NCT01914913
Lead sponsor
Chaitanya Hospital, Pune
Responsible party
Dr. Sachin Jamadar (Co -investigator, Chaitanya Hospital, Pune) — Principal investigator
First posted
Aug 2, 2013
Start date
Sep 2014
Primary completion
Nov 2016 (estimated)
Completion
Nov 2016 (estimated)
Last update
Sep 17, 2014

Study contacts

Sachin P Jamadar, D.Ortho
Contact
sac2751982@gmail.com
918888788880
ANANT E BAGUL, MS ORTHO
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.

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Discussion

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