ConditionRetinitis Pigmentosa
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPT. Prodia Stem Cell Indonesia
About this trial
The study will perform UC-MSCs and CM transplantation. There are two groups with different dosages. The first group will be transplanted with 1.5 million cells, meanwhile, the second group is 5 million cells. Each group consists of 30 subjects. All groups will be transplanted via the peribulbar route. All groups will be observed until six months.
Eligibility criteria
Qualifiers
Visus more than 20/100
Have more than 0.68 uV on conical receptor cell amplitude checked by ERG
Visual field equivalent diameter more than 10o
Willing to sign informed consent as research subjects
Disqualifiers
Pregnant or nursing women
Positive result of HIV test
Have a history of eye tumors
Under immunosuppressive treatment or other drugs that can affect the growth of transplanted stem cells
Trial design
Treatments tested in this trial
- 1.5 x 10^6 UC-MSC + CM
- 5 x 10^6 UC-MSC + CM
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov