Role of UC-MSC and CM to Inhibit Vision Loss in Retinitis Pigmentosa Phase I/II

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 groups

Sponsors and collaborators