Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06142981
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2023-11-13
Brief Title:
PRP and PBD-VSEL Stem Cell Therapy for Parkinsons Disease
Sponsor:
Fatima Jinnah Medical University
Organization:
Fatima Jinnah Medical University
Study Overview
Official Title:
Effectiveness of Regenerative Medicine PRP and PBD-VSEL Stem Cell Therapy for Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parkinsons Disease Rating Scale UPDRS Hospital Anxiety and Depression Scale HADS and self-report Parkinsons Disease Questionnaire-39 PDQ-39
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 Parkinsons Disease Rating Scale UPDRS Hospital Anxiety and Depression Scale HADS and self-report Parkinsons Disease Questionnaire-39 PDQ-39
Detailed Description:
Parkinsons 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 Parkinsons 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 Parkinsons Disease Rating Scale UPDRS Hospital Anxiety and Depression Scale HADS and self-report Parkinsons Disease Questionnaire-39 PDQ-39 All the data will be entered and analyzed by SPSS 250 Before and after difference outcome variables will compared before and after difference will be observed by paired sample t test P-value 005 will be considered as significant
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 Parkinsons Disease Rating Scale UPDRS Hospital Anxiety and Depression Scale HADS and self-report Parkinsons Disease Questionnaire-39 PDQ-39 All the data will be entered and analyzed by SPSS 250 Before and after difference outcome variables will compared before and after difference will be observed by paired sample t test P-value 005 will be considered as significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None