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Research study on information about experimental stem cell treatments for stroke

Effectiveness of patient education in changing stroke survivor attitudes toward unregulated and experimental stem cell treatments: A randomized controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001094268
Acronym
None
Enrollment
222
Registered
2018-06-29
Start date
2018-06-29
Completion date
2019-01-01
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This research study is examining whether patient education booklets and videos are a clear and informative way of communicating information about the safety, effectiveness, accessibility and affordability of experimental stem cell treatments (i.e. stem cell injections to the brain, spinal cord, vein, artery or stomach) offered by private clinics in China, India, Russia and South America.

Interventions

This study will be conducted online. Participants will be randomly allocated to one of two intervention groups (Arm 1, 2) or one control group (Arm 3: discussed in the next section). First, participants in Arms 1 and 2 will be asked to provide some background information (e.g., age, gender, stroke type/year) and details of their current physical, cognitive and emotional functioning. Immediately after this, participants will be asked to complete a brief survey (6 questions) about experimental st

This study will be conducted online. Participants will be randomly allocated to one of two intervention groups (Arm 1, 2) or one control group (Arm 3: discussed in the next section). First, participants in Arms 1 and 2 will be asked to provide some background information (e.g., age, gender, stroke type/year) and details of their current physical, cognitive and emotional functioning. Immediately after this, participants will be asked to complete a brief survey (6 questions) about experimental stem cell treatments (e.g. perceived risks, benefits, accessibility, affordability). Arm 1: Participants in Arm 1 will then be directed via a web link to an information booklet produced by the International Society for Stem Cell Research (ISSCR). Topics covered in the booklet include: what are stem cells, the risks and benefits associated with different types of stem cell treatments, and the difference between treatments offered by private clinics and those offered within clinical trials. The booklet is expected to take approximately 30 minutes to read and participants will need to do so at that time. After confirming that they have read the booklet, participants will be asked to recomplete the previous survey about experimental stem cell treatments. The first stage of the study ends here for Arm 1. Participants will then be emailed 30-days after completing this stage to reconfirm their attitudes toward experimental stem cell treatments by completing the previously administered survey. Arm 2: Participants in Arm 2 will then be directed via a web link to watch a patient information video (1.17 minutes in length) produced by the Stem Cell Network. Topics covered in the video include: the current state of stem cell treatment research, the risks associated with having experimental stem cell treatments, and how researchers and regulatory bodies determine if treatments are safe and effective for patients to use. After confirming that they have watched the video, participants will be asked to recomplete the previous survey about experimental stem cell treatments. The first stage of the study ends here for Arm 2. Participants will then be emailed 30-days after completing this stage to reconfirm their attitudes toward experimental stem cell treatments by completing the previously administered survey.

Sponsors

University of Adelaide
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

English-speaking, adult, stroke survivors who have not previously had experimental stem cell injections, either as a treatment for their stroke/stroke-related symptoms (e.g. pain), or any other medical or neurological disorder, and who are able to provide consent (personally or via a third party).

Exclusion criteria

Stroke survivors aged less than 18 years (at time of survey) and/or have previously had experimental stem cell injections, either as a treatment for their stroke/stroke-related symptoms (e.g. pain), or other medical or neurological disorder.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026