Clinical trial NCT06142981: PRP and PBD-VSEL Stem Cell Therapy for Parkinson's Disease
Official title: Effectiveness of Regenerative Medicine (PRP and PBD-VSEL Stem Cell Therapy) for Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regenerative Medicine
Keywords: Parkinson's Disease
PRP
Stem cells
Safety
Lead sponsor: Fatima Jinnah Medical University
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* The diagnosis of clinically established PD for at least 1-3 years,
* Both genders aged between 30 to 50 years
* On stable therapy (dopaminergic medication and/or deep brain stimulation parameters)

Exclusion Criteria:

* Gout, congestive heart failure, renal failure
* Uncontrolled atrial fibrillation, stroke, anaphylaxis, blood clotting problem,
* Clinical suspicion or diagnosis of atypical forms of parkinsonism or essential tremor

Primary outcomes:
measure: The Unified Parkinson's Disease Rating Scale The Unified Parkinson's Disease Rating Scale
timeFrame: 1 year
measure: Hospital Anxiety and Depression Scale
timeFrame: 3 to 12 months
measure: Parkinson's Disease Questionnaire-39
timeFrame: 1 to 11 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: gull e Rukh
state: Punjab
Study officials:
affiliation: University of Lahore
name: shehzad Anwar
role: PRINCIPAL_INVESTIGATOR
References: