NCT06142981

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

November 13, 2023

Last Update Submit

January 3, 2026

Conditions

Regenerative Medicine

Keywords

Parkinson's DiseasePRPStem cellsSafety

Outcome Measures

Primary Outcomes (3)

  • The Unified Parkinson's Disease Rating Scale The Unified Parkinson's Disease Rating Scale

    There are four sections of the Unified Parkinson's Disease Rating Scale (UPDRS): four items are used in Part I to assess mentality, behavior, and mood; 13 items are used in Part II to assess activities of daily living; 27 items are used in Part III to measure motor examination; and 11 items are used in Part IV to assess complications of therapy. Each symptom or sign associated with Parkinson's disease is rated on a 5-point Likert scale with scores ranging from 0 to 4.Higher scores indicate more severe impairment. The maximum total UPDRS score of 200 indicates the highest degree of disability caused by Parkinson's disease.

    1 year

  • Hospital Anxiety and Depression Scale

    The Hospital Anxiety and Depression Scale (HADS) is a 14-item questionnaire for measuring anxiety and depression. The maximum score for anxiety or depression is 21, with each item having a value between 0 (no impairment) and 3 (significant impairment).

    3 to 12 months

  • Parkinson's Disease Questionnaire-39

    The Parkinson's Disease Questionnaire (PDQ-39) assesses the frequency of challenges faced by people with Parkinson's disease in eight areas of daily life, including relationships, social interactions and communication. The PDQ-39 assigns scores on a scale of 0 to 100 for each of the eight dimensions, with higher scores indicating poorer quality of life.

    1 to 11 months

Study Arms (1)

Experimental group

EXPERIMENTAL

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.

Biological: PRP and PBD-VSEL Stem Cell therapy

Interventions

PRP and PBD-VSEL Stem Cell therapyBIOLOGICAL

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.

Experimental group

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

gull e Rukh

Lahore, Punjab Province, 54780, Pakistan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • shehzad Anwar

    University of Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 13, 2023

First Posted

November 22, 2023

Study Start

September 10, 2019

Primary Completion

September 15, 2022

Study Completion

December 15, 2022

Last Updated

January 6, 2026

Record last verified: 2026-01

Locations

PA(1)