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Safety Issues of Peribulbar Injection of UC-MSC in Patients With Retinitis Pigmentosa

NCT04315025 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-06-04

No results posted yet for this study

Summary

The study will perform UC-MSCs and CM transplantation. The first group will be injected by UCMSC+NaCl. the 2nd group will be injected by UC-MSC+CM. the 3rd group will be injected by CM. Each group consists of 6 subjects. all groups will be transplanted via peribulbar route. the dosage of UC-MSC is 1 million cells for each subject. All groups will be observed until 6 months.

Conditions

Interventions

BIOLOGICAL

Umbilical Cord Mesenchymal Stem Cell (UC-MSC)

Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar

BIOLOGICAL

Conditioned Medium (CM)

Conditioned Medium (CM) injected by peribulbar

Sponsors & Collaborators

  • PT. Prodia Stem Cell Indonesia

    lead INDUSTRY

Principal Investigators

  • dr Cosmos O Mangunsong, Sp.M · Gadjah Mada University, Faculty of Medicine

  • Professor dr. Yohanes W Wirohadidjojo, Sp.KK(K), PhD · Gadjah Mada University, Faculty of Medicine

  • Bayu W Putera, S.Si, M.Kes · Prodia Stem Cell Indonesia

  • dr Bayu M Sasongko, Sp.M, PhD · Gadjah Mada University, Faculty of Medicine

  • dr Melita S Djaja, Sp.M · Jakarta Eye Center

  • dr Amyra D Costa · Jakarta Eye Center

  • Rima Haifa, B.Sc · Prodia StemCell Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-07
Primary Completion
2019-06-20
Completion
2019-09-20

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04315025 on ClinicalTrials.gov