PRP and PBD-VSEL Stem Cell Therapy for Parkinson's Disease
Condition: Regenerative Medicine
MeSH terms: Parkinson Disease
Study type: Interventional

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.
    

Intervention name(s): PRP and PBD-VSEL Stem Cell therapy
Intervention type(s): Biological
Intervention description(s): The intervention 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's Disease; PRP; Stem cells; Safety