PRP and PBD-VSEL Stem Cell Therapy for Parkinson's Disease

NCT ID: NCT06142981

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-10

Study Completion Date

2022-12-15

Brief Summary

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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

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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.

Conditions

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Regenerative Medicine

Keywords

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Parkinson's Disease PRP Stem cells Safety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group

Patients will receive 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.

Group Type EXPERIMENTAL

PRP and PBD-VSEL Stem Cell therapy

Intervention Type BIOLOGICAL

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.

Interventions

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PRP and PBD-VSEL Stem Cell therapy

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 Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fatima Jinnah Medical University

OTHER

Sponsor Role lead

Responsible Party

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Humaira Waseem

[email protected]

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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shehzad Anwar

Role: PRINCIPAL_INVESTIGATOR

University of Lahore

Locations

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gull e Rukh

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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SPRM-101

Identifier Type: -

Identifier Source: org_study_id