Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06142981 |
Other study ID # |
SPRM-101 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 10, 2019 |
Est. completion date |
December 15, 2022 |
Study information
Verified date |
November 2023 |
Source |
Fatima Jinnah Medical University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
An experimental study will be conducted at Iffat Anwar medical complex conducted to evaluate
the effectiveness of PRP and stem Cell therapy in the treatment of PD. After the initial
cognitive and laboratory testing, the first infusion appointment will be planned within 2
weeks.
- The treatment began with the administration of three PRP sessions, where the patients
received intravenous injections at four acupuncture points (stomach 36 and GB 34 on both
sides) at the 1st, 2nd, and 3rd month.
- After three months of treatment, patients were sent back to the neurophysician for
evaluation. They will be given a booster dose of PRP during the 1-year follow-up, and
then monitored every six months for the next two years.
The primary outcomes of the study will beto see the improvement in The Unified Parkinson's
Disease Rating Scale (UPDRS), Hospital Anxiety and Depression Scale (HADS) and self-report
Parkinson's Disease Questionnaire-39 (PDQ-39).
Description:
Parkinson's disease the second most common neurological disease worldwide is a progressive
disorder that affects movement and can cause tremors, stiffness, and difficulty with
coordination and balance caused by dopamine deficiency and progressive degeneration of
dopaminergic neurons (DAn). Autologous Platelet Rich Plasma (PRP) and Stem cell therapy is
new and practical treatment option that aims to decrease neuroinflammation, modulate immune
system and stimulate, replace or repair lost or damaged dopamine-producing cells in the brain
lost in Parkinson's disease.
Methods:
Total 30 patients aged 30 - 50 years will enrolled in the study. After the initial cognitive
and laboratory testing, the patients will be infused PRP in the autologous blood, once a
month for 2 months. After three monthly sessions of PRP treatments, peripheral blood derived
very small embryonic like (PBD-VSEL) stem cells therapy will be done on the 90th day. All the
patients will be sent to neuro physicians for evaluation and improvement after 3 months, 6
months and 12 months.
The primary outcomes of the study will be to see the improvement in The Unified Parkinson's
Disease Rating Scale (UPDRS), Hospital Anxiety and Depression Scale (HADS) and self-report
Parkinson's Disease Questionnaire-39 (PDQ-39). All the data will be entered and analyzed by
SPSS 25.0. Before and after difference outcome variables will compared before and after
difference will be observed by paired sample t test. P-value <0.05 will be considered as
significant.