NCT01914913

Brief 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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2013

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

September 17, 2014

Status Verified

September 1, 2014

Enrollment Period

2.2 years

First QC Date

July 31, 2013

Last Update Submit

September 16, 2014

Conditions

Retinitis Pigmentosa

Keywords

retinitis pigmentosaBone marrowstem cellBMMNC

Outcome Measures

Primary Outcomes (1)

  • visual acuity

    Electronic Visual Acuity (EVA) technology

    1 YEAR

Study Arms (1)

BMMNCs

OTHER

BMMNCs

Biological: BMMNCs

Interventions

BMMNCsBIOLOGICAL

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

BMMNCs

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaitanya Hospital

Pune, Maharashtra, 411030, India

RECRUITING

MeSH Terms

Conditions

Retinitis Pigmentosa

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • ANANT E BAGUL, MS ORTHO

    Chaitanya Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sachin P Jamadar, D.Ortho

CONTACT

918888788880sac2751982@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co -investigator

Study Record Dates

First Submitted

July 31, 2013

First Posted

August 2, 2013

Study Start

September 1, 2014

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

September 17, 2014

Record last verified: 2014-09

Locations

IN(1)