Regenerative MedicineNCT06142981
PRP and PBD-VSEL Stem Cell Therapy for Parkinson's Disease
A study testing PRP and PBD-VSEL Stem Cell therapy in people with Regenerative Medicine, run by Fatima Jinnah Medical University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Regenerative Medicine
- What is being tested?
- PRP and PBD-VSEL Stem Cell therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Sep 2019to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Regenerative Medicine (PRP and PBD-VSEL Stem Cell Therapy) for Parkinson's Disease
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).
Read the 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.
- Conditions
- Regenerative Medicine
- Being tested
- PRP and PBD-VSEL Stem Cell therapy
- Keywords
- Parkinson's Disease, PRP, Stem cells, Safety
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: PRP and PBD-VSEL Stem Cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 1 to 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start10 Sep 2019
- Primary completion15 Sep 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regenerative MedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatima Jinnah Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Humaira Waseem, Fatima Jinnah Medical University
- Investigators
- shehzad Anwar, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142981
- Sponsor's protocol ID
- SPRM-101
- Status last verified
- Jan 2026
- First submitted
- 13 Nov 2023
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Regenerative Medicine (PRP and PBD-VSEL Stem Cell Therapy) for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06142981
- Acronym / sponsor ID
- SPRM-101
- Conditions
- Regenerative Medicine
- Keywords
- Parkinson's Disease, PRP, Stem cells, Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fatima Jinnah Medical UniversityUniversity, hospital or other
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Biological: PRP and PBD-VSEL Stem Cell therapyPatients 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. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP and PBD-VSEL Stem Cell therapyThe 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. | Biological | Experimental group |
Primary outcome
The Unified Parkinson's Disease Rating Scale The Unified Parkinson's Disease Rating Scale
Time frame: 1 year
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.
Hospital Anxiety and Depression Scale
Time frame: 3 to 12 months
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).
Parkinson's Disease Questionnaire-39
Time frame: 1 to 11 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
shehzad Anwar principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP and PBD-VSEL Stem Cell therapy in people with Regenerative Medicine, run by Fatima Jinnah Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Unified Parkinson's Disease Rating Scale The Unified Parkinson's Disease Rating Scale (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.